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Background Zinc supplementation has been considered a potential therapy for coronavirus disease 2019 (COVID-19). We aimed to examine zinc efficacy in adult patients with COVID-19 infection. Methods We conducted a prospective, randomized, double-blind, placebo-controlled multicenter trial. Patients who were tested positive for COVID-19 without end-organ failure were randomized to oral zinc (n = 231) or matching placebo (n = 239) for 15 days. The primary combined outcome was death due to COVID-19 or intensive care unit (ICU) admission ≤30 days after randomization. Secondary outcomes included length of hospital stay for inpatients and duration of COVID-19 symptoms with COVID-19–related hospitalization for outpatients. Results 190 patients (40.4%) were ambulatory and 280 patients (59.6%) were hospitalized. Mortality at 30 days was 6.5% in the zinc group and 9.2% in the placebo group (OR: .68; 95% CI .34–1.35); ICU admission rates were, respectively, 5.2% and 11.3% (OR: .43; 95% CI .21–.87). Combined outcome was lower in the zinc group versus the placebo group (OR: .58; 95% CI .33–.99). Consistent results were observed in prespecified subgroups of patients aged Conclusions Our results showed that, in COVID-19 patients, oral zinc can decrease 30-day death, ICU admission rate and can shorten symptom duration. Clinical Trials Registration. ClinicalTrials.gov, NCT05212480.

Background Rapid diagnosis of heart failure (HF) in acutely dyspneic patients can be challenging for emergency department (ED) physicians. Hypothesis Cardiac output (CO) change with sublingual nitroglycerin (NTG) could be helpful in the diagnosis of HF in patients with acute undifferentiated dyspnea. Materials and Methods A prospective study of patients >18 years admitted to the ED for acute dyspnea. Using thoracic bioimpedance, we measured CO change at baseline and after sublingual administration of 0.6 mg of NTG. HF was defined on the basis of clinical examination, pro‐brain natriuretic peptide levels, and echocardiographic findings. Diagnostic performance of delta CO was calculated by sensitivity, specificity, likelihood ratio and receiver operating characteristic (ROC) curve. Results This study included 184 patients with mean age of 64 years. Baseline CO was comparable between the HF group and the non‐HF group. At its best cutoff (29%), delta CO showed good accuracy in the diagnosis of HF with a sensitivity, specificity, positive and negative likelihood ratios of 80%, 44%, 57%, and 66% respectively. Area under ROC curve was 0.701 [95% CI 0.636–0.760]. The decrease of CO with sublingual NTG was significantly higher in patients with HFpEF compared with those with HFrEF. Multivariate analysis, showed that delta CO was an independent factor associated with HF diagnosis [OR 0.19 (95% CI 0.11–0.29); p

Objective The study compared the efficacy and tolerability of piroxicam gel and a new topical combination of medicinal plant products (Soulagel®; Belpharma Tunisia) to treat pain caused by soft tissue injuries. Methods Patients (n = 1,525) were assigned to receive piroxicam gel or Soulagel. Efficacy assessments included a change of at least 50% in the pain-on-movement visual numeric scale rating from emergency department discharge (baseline) to day 7 final assessment, as well as the time required to reach pain resolution criteria, the need for rescue analgesia, patients’ satisfaction, and the rate of adverse effects. Results At day 7, 1,216 patients (79.7%) achieved at least 50% reduction in visual numeric scale rating from baseline: 623 patients (82.4%) in the Soulagel group vs 593 patients (77.1%) in the piroxicam group (P = 0.01). Time to decrease pain on movement by 50% was significantly higher with piroxicam gel than with Soulagel (34 ± 1 vs 33 ± 1 days, respectively; P = 0.54). At day 7, 96.4% of patients in the Soulagel group declared being “very satisfied” to “satisfied,” vs 68% in the piroxicam group (P Conclusions Soulagel is not inferior to piroxicam gel for managing pain related to a soft tissue injuries. Further studies will help ascertain whether this new gel offers an alternative treatment option for this common emergency department condition.

Duration of antibiotic treatment in acute exacerbation of COPD (AECOPD) is most commonly based on expert opinion. Typical administration periods range from 5 to 7 days. A 2-day course with levofloxacin was not previously assessed. We performed a randomized clinical trial to evaluate the efficacy of 2-dayPatients with AECOPD were randomized to receive levofloxacin for 2 days and 5 days placebo (310 patients were randomized to receive 2-day course of levofloxacin (Levofloxacin once daily for 2 days is not inferior to 7 days with respect to cure rate, need for additional antibiotics and hospital readmission in AECOPD. Our findings would improve patient compliance and reduce the incidence of bacterial resistance and adverse effects.

Objectives Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (also called paracetamol) are the most frequent analgesics used to relieve posttrauma pain in the emergency department (ED). However, the utility of combining both treatments is still controversial. We sought to explore the benefits of combining an NSAID with acetaminophen compared to acetaminophen alone, or NSAID alone, in the treatment of posttraumatic pain of the extremity after discharge from the ED. Methods This is a prospective, randomized controlled trial, carried out in a single ED from March 2017 to November 2018. The included patients were randomly assigned to receive paracetamol alone, high-dose NSAID (piroxicam) alone, or a combination of paracetamol and high-dose NSAID for 7 days after ED discharge. The primary outcome was need for additional oral analgesics. Secondary outcomes included the change of the visual numeric scale (VNS) between ED discharge (VNS D0) and 7 days later (VNS D7), ED revisits for residual pain, side effects, and patient satisfaction as assessed by a Likert satisfaction scale. Results The need for additional oral analgesics was comparable between the paracetamol-NSAID combination group (9.8%) and the paracetamol group (11.4%; p = 0.43). ED readmission rate was also comparable between the two groups at 5.6 and 5.8%, respectively (p = 0.86). In contrast, need for new analgesics and ED revisit rates were both more frequent in the high-dose NSAID group. Mean VNS decreases on day 7 compared to day 0 were 66, 63, and 67%, respectively, in the paracetamol, NSAID, and paracetamol-NSAID combination groups (p = 0.32). Frequency of dissatisfaction was higher in the NSAID group. Side effects were more frequent in the NSAID and paracetamol-NSAID combination groups. Conclusion This study found that the combination of a high-dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high-dose NSAID alone for posttraumatic extremity pain.

OBJECTIVES To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine on reducing the need for opioid and nonopioid analgesic agents in emergency department (ED) patients with acute moderate to severe acute limbs' trauma pain. PATIENTS AND METHODS This is a double-blind, randomized, prospective, controlled study conducted in the ED. The included patients were randomly assigned to intranasal pulverization of ketamine or placebo. Protocol treatment was given at the triage. The primary outcome is the need for opioids during ED stay. Secondary outcome included the requirement of nonopioid analgesic agents and the percentage of patients discharged from the ED with a visual analog scale (VAS)

Background: Heart failure (HF) is commonly associated with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) but its role is often underestimated. Aim of study: To evaluate the performance of a new diagnostic technique based on the measurement of the pulse amplitude ratio (PAR) using non-invasive ventilation (NIV) for the early identification HF in patients admitted to the emergency department (ED) for AECOPD.Methods: This is a prospective observational study including patients presenting to the ED with AECOPD. Each included patient received NIV with inspiratory pressure support (PS) set at 5 and 30 cmH2O for 15 min in random order. We measured plethesmographic pulse pressure (PP) at PS of 5cmH2O (PP5) and 30 cmH2O (PP30). We calculated the PAR under NIV (PARNIV) as the PP30 /PP5 ratio. Patients were divided into two groups: a group identified as having HF (HF group) and a group without HF (non HF group). The diagnostic performance of PARNIV was assessed by standard methods.Results: 73 patients were included in this study: 32 in HF group and 41 in non HF- group. The two groups had comparable demographic and clinical characteristics at admission. The mean values of PARNIV was significantly higher among HF patients (0.86 versus 0.71; pNIV was 0.75. Using the best cut-off (0.6), the sensitivity of PARNIV was 93% with a specificity 21%, a positive predictive value of 48%, and a negative predictive value of 81%. Correlation between PARNIV and BNP was significant (r =0.52; p=0.002)Conclusion: Measurement of PARNIV in patients presenting to the ED with AECOPD had a good diagnostic performance for the detection of HF and could represent an interesting alternative for the currently available methods.The study was registered in the Clinical Trial Registration System (clinicaltrials.gov) under the study number NCT05189119.

BackgroundLittle is known about the pattern and appropriateness of antibiotic prescriptions in patients with acute respiratory tract infections (ARTIs).Objective Describe the antibiotics used to treat ARTIs in Tunisian primary care offices and emergency departments (EDs), and assess the appropriateness of their use.MethodsIt was a multicenter cross-sectional observational clinical study conducted at 63 primary care offices and 6 EDS during a period of 8 months. Appropriateness of antibiotic prescription was evaluated by trained physicians using the medication appropriateness index (MAI). The MAI ratings generated a weighted score of 0 to 18 with higher scores indicating low appropriateness. The study was conducted in accordance with the Declaration of Helsinki and national and institutional standards. The study was approved by the Ethics committee of Monastir Medical Faculty.ResultsFrom the 12880 patients screened we included 9886 patients. The mean age was 47.4, and 55.4% were men. The most frequent diagnosis of ARTI was were acute bronchitis (45.3%), COPD exacerbation (16.3%), tonsillitis (14.6%), rhinopharyngitis (12.2%) and sinusitis (11.5%). The most prescribed classes of antibiotics were penicillins (58.3%), fluoroquinolones (17.6%), and macrolides (16.9%). Antibiotic therapy was inappropriate in 75.5% of patients of whom 65.2% had bronchitis. 65% of patients had one or more antibiotic prescribing inappropriateness criteria as assessed by the MAI. The most frequently rated criteria were with expensiveness (75.8%) and indication (40%). Amoxicillin-clavulanic acid and levofloxacin were the most inappropriately prescribed antibiotics. History of cardiac ischemia ([OR] 3.66; 95% [CI] 2.17-10.26; p65 years (Odds Ratio [OR] 1.35, 95% confidence interval [CI] 1.16-1.58; pConclusionOur findings indicate a high inappropriate use of antibiotics in ARTIs treated in in primary care and EDs. This was mostly related to antibiotic prescription in acute bronchitis and overuse of expensive broad spectrum antibiotics. Future interventions to improve antibiotic prescribing in primary care and EDs is needed.Trial registrationthe trial is registered at Clinicaltrials.gov registry (NCT04482231)

Background: The AGE Reader, as a clinical tool for non invasive assessment, measures the accumulation of advanced glycation end products (AGEs) in skin tissues shown as skin autofluorescence (SAF). AGEs Accumulation has been implicated in several diseases. There is no data about SAF profile in Tunisian population, this study aimed to assess firstly SAF profile in subjects with and without metabolic disorders and secondly to examine the association between SAF and various clinical parameters.Methods: In a cross-sectional study, we included 220 participants between 19 and 86 years of age who were subdivided in two groups: a healthy group (n=93) and patients group with metabolic disorders (n=127) contains three subgroups as following: diabetic patients (n=32), hypertensive patients (n=54) and patients with both diabetes and hypertension (n=41). Skin AGEs accumulation was measured by AGE Reader and clinical data was obtained.Results: SAF was significantly higher in patients group compared to healthy group [2.40 AU (2.10-2.60) vs. 2.00 AU (1.70-2.10) respectively; P 2.25 AU was optimal cut-off point to predict the presence of metabolic disorders (P Conclusion: SAF was increased in patients with diabetes and/or with hypertension and dyslipidemia. AGE Reader device is a rapid and helpful tool in clinical practice for evaluating and screening metabolic disorders in undiagnosed subjects.

Background Little is known about the pattern and appropriateness of antibiotic prescriptions in patients with acute respiratory tract infections (ARTIs). Objective Describe the antibiotics used to treat ARTIs in Tunisian primary care offices and emergency departments (EDs), and assess the appropriateness of their use. Methods It was a prospective multicenter cross-sectional observational clinical study conducted at 63 primary care offices and 6 EDS during a period of 8 months. Appropriateness of antibiotic prescription was evaluated by trained physicians using the medication appropriateness index (MAI). The MAI ratings generated a weighted score of 0 to 18 with higher scores indicating low appropriateness. The study was conducted in accordance with the Declaration of Helsinki and national and institutional standards. The study was approved by the Ethics committee of Monastir Medical Faculty. Results From the 12,880 patients screened we included 9886 patients. The mean age was 47.4, and 55.4% were men. The most frequent diagnosis of ARTI was were acute bronchitis (45.3%), COPD exacerbation (16.3%), tonsillitis (14.6%), rhinopharyngitis (12.2%) and sinusitis (11.5%). The most prescribed classes of antibiotics were penicillins (58.3%), fluoroquinolones (17.6%), and macrolides (16.9%). Antibiotic therapy was inappropriate in 75.5% of patients of whom 65.2% had bronchitis. 65% of patients had one or more antibiotic prescribing inappropriateness criteria as assessed by the MAI. The most frequently rated criteria were with expensiveness (75.8%) and indication (40%). Amoxicillin-clavulanic acid and levofloxacin were the most inappropriately prescribed antibiotics. History of cardiac ischemia ([OR] 3.66; 95% [CI] 2.17–10.26; p p p = 0.003), history of COPD ([OR] 1.75, 95% [CI] 1.43–2.15; p 65 years (Odds Ratio [OR] 1.35, 95% confidence interval [CI] 1.16–1.58; p Conclusion Our findings indicate a high inappropriate use of antibiotics in ARTIs treated in in primary care and EDs. This was mostly related to antibiotic prescription in acute bronchitis and overuse of expensive broad spectrum antibiotics. Future interventions to improve antibiotic prescribing in primary care and EDs is needed. Trial registration the trial is registered at Clinicaltrials.gov registry (NCT04482231).

OBJECTIVES To evaluate the effect on opioid requirement of pain treatment starting at triage, and to evaluate satisfaction in emergency department (ED) patients with acute pain. METHODS This is a single-blind, randomized, prospective study conducted in the ED. The included patients were randomly assigned to single oral doses of placebo, acetaminophen, or a tramadol/acetaminophen combination. Protocol treatment was given at triage. The primary outcome was the need for rescue morphine during ED stay. The secondary outcome included patient satisfaction, ED length of stay, and percentage of patients discharged from the ED with a VAS score of

Introduction: Duration of antibiotic treatment in acute exacerbation of COPD (AECOPD) is most commonly based on expert opinion. Typical administration periods range from 5 to 7 days. A 2-day course with levofloxacin was not previously assessed. We performed a randomized clinical trial to evaluate the efficacy of 2-day versus 7-day treatment with levofloxacin in patients with AECOPD.Methods: Patients with AECOPD were randomized to receive levofloxacin for 2 days and 5 days placebo (n=155) or levofloxacin for 7 days (n=155). The primary outcome measure was cure rate, and secondary outcome included need for additional antibiotics, ICU admission, reexacerbation rates and exacerbation free interval (EFI) within one year follow-up. Results: In ITT analysis, cure rate was 79.3% (n=123) and 74.2% (n=115) respectively in 2-day and 7-day groups. In PP analysis, cure rate was 78% (n=92) and 69% (n=82) respectively in 2-day and 7-day groups. The difference between both groups was not significant. The need for additional antibiotics and ICU admission rates were not significantly different between both groups. One-year reexacerbation rate was 34.8% (n=54) in 2-day group versus 29% (n=45) in 7-day group (p=0.19); the EFI was 121 days (interquartile range, 99-149) versus 110 days (interquartile range, 89-132) in 2-day and 7-day treatment groups respectively (p=0.73). No difference in adverse effects was detected.Conclusion: Levofloxacin once daily for 2 days is not inferior to 7 days with respect to cure rate and hospital readmission in COPD exacerbations. Our finings would improve patient compliance and reduce the incidence of bacterial resistance and adverse effects.

Aim of study Cardiac output (CO) responses to acute changes in body position and Valsalva maneuver (VM) were proposed to assess cardiac contractile reserve. We investigated the value of sitting position (SP), leg raising (LR), and VM for identifying heart failure (HF) in patients with undifferentiated dyspnea. Materials and methods It is a prospective study including patients over 18 years old admitted to the emergency department (ED) for dyspnea. Bioimpedance CO was measured at baseline, under SP, LR, and VM. HF diagnosis was based on clinical assessment, serum levels of brain natriuretic peptide (BNP) and echocardiography findings. Study population was divided into patients with heart failure (HF group) and patients without HF (HF- group). Diagnostic performance of CO change under the three maneuvers was calculated by sensitivity, specificity, likelihood ratio and receiver operating characteristic (ROC) curve. Results 290 patients were enrolled in the study. The final diagnosis was dyspnea due to congestive heart failure in 147 patients (50.7%). CO change with VM was the most accurate exam in identifying congestive heart failure as the cause of dyspnea with a sensitivity, specificity, positive and negative likelihood ratios of 79%, 60%, 1.97, and 0.36 respectively. Area under ROC curve was 0.62(95% CI, 0.55–0.69), 0.63(95% CI, 0.56–0.69), and 0.70(95% CI, 0.64–0.76) respectively for SP, LR, and VM. In a multivariate analysis, CO change with VM, but not with SP or LR, carried independent diagnostic value (p Conclusion the diagnosis of HF can be aided with use of analyzing the effect of VM on non-invasively measured CO among patients admitted to the ED with undifferentiated dyspnea. Diagnostic yield of SP and LR was poor.

Background Short-acting β2 -agonists are the mainstay of treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in the emergency department (ED). It is still unclear whether the addition of short-acting anticholinergics is clinically more effective care compared to treatment with β2 -agonists alone in patients with hypercapnic AECOPD. Objective The objective was to evaluate whether combining ipratropium bromide (IB) to terbutaline reduces hospital and intensive care unit (ICU) admission rates compared to terbutaline alone in AECOPD hypercapnic patients. Methods In this double-blind controlled trial, patients who were admitted to the ED for AECOPD requiring noninvasive ventilation (NIV) were randomized to receive either 5 mg of nebulized terbutaline combined to 0.5 mg of IB (terbutaline/IB group, n = 115) or 5 mg of terbutaline sulfate (terbutaline group, n = 117). Nebulization was repeated every 20 minutes for the first hour and every 4 hours within the first day. Primary outcomes were the rate of hospital admission and need for endotracheal intubation within the first 24 hours of the start of the experimental treatment. Secondary outcomes included changes from baseline of dyspnea, physiologic variables, length of hospital stay, ICU admission rate, and 7-day mortality. Results The two groups were similar regarding baseline demographic and clinical characteristics. Hospital admission was observed in 70 patients (59.8%) in the terbutaline/IB group and in 75 patients (65.2%) in the terbutaline group (respiratory rate [RR] = 1.09, 95% confidence interval [CI] = 0.93 to 1.27, p = 0.39). ICU admission was required in 37 (32.2%) patients in the terbutaline/IB group and 30 patients (25.6%) in terbutaline group (RR = 1.25, 95% CI = 1.02 to 1.54, p = 0.27). There were no significant differences in dyspnea score, blood gas parameters changes, vital signs improvement, and 7-day death rate between both groups. Conclusion In patients admitted to the ED for AECOPD requiring NIV, combination of nebulized IB and terbutaline did not reduce hospital admission and need to ICU care.

Kaouthar Beltaief,1,2 Mohamed Habib Grissa,1,2 Mohamed Amine Msolli,1,2 Nasri Bzeouich,1,2 Nizar Fredj,1,2 Adel Sakma,1,2 Hamdi Boubaker,1,2 Wahid Bouida,1,2 Riadh Boukef,1,3 Semir Nouira1,2 1Emergency Department, Fattouma Bourguiba University Hospital, 2Research Laboratory LR12SP18, University of Monastir, Monastir, 3Emergency Department, Sahloul University Hospital, Sousse, Tunisia Objective: The objective of this study was to compare the analgesic effect and tolerance profile of acupuncture versus intravenous (IV) titrated morphine in patients presenting to the emergency department (ED) with renal colic.Materials and methods: A total of 115 patients were randomized into two groups. Patients in the IV titrated-morphine group (n=61) received 0.1 mg/kg morphine every 5 minutes until pain score dropped by at least 50% of its baseline value. Patients in the acupuncture group (n=54) received an acupuncture session of 30 minutes following a prespecified protocol. The visual analog scale (VAS) was used to assess pain intensity at baseline and at 10, 20, 30, 45, and 60 minutes following the start of the treatment protocol. Possible treatment side effects were also recorded.Results: No significant differences were found between the two groups concerning age, sex, or baseline VAS score. From the 10th minute until the end of the intervention, acupuncture was associated with a deeper analgesic effect than titrated morphine (P

AIM OF THE STUDY The diagnosis of heart failure in the emergency department (ED) is challenging. The aim of this study was to evaluate systolic time intervals (STIs) using phonoelectrocardiography for the diagnosis of heart failure (HF) in ED patients with undifferentiated dyspnea. METHODS A total of 855 patients with dyspnea and suspected HF were prospectively enrolled. They underwent echocardiographic measurements of left ventricular ejection fraction (LVEF), B-type natriuretic peptide (BNP) testing and computerised phonoelectrocardiography to assess STIs including electromechanical activation time (EMAT), left ventricular ejection time (LVET) and EMAT/LVET ratio. Diagnosis accuracy of STIs was calculated including sensitivity, specificity, likelihood ratio and receiver operating characteristic (ROC) curve. RESULTS Patients with HF (n = 530) had significantly higher EMAT and lower LVET compared with non-HF patients. ROC curve c-statistic was 0.74, 0.72 and 0.78 for EMAT, LVET and EMAT/LVET respectively. Sensitivity and specificity of EMAT/LVET at a cut-off = 40% were 72% and 88% respectively. EMAT/LVET had the highest correlation with LVEF (r = 0.48). In patients with intermediate BNP (n = 107), positive likelihood ratio increased from 1.8 with BNP alone to 3.6 with BNP combined to EMAT/LVET. Patients without HF had STIs values not significantly different from those with preserved LVEF (≥45%). CONCLUSIONS Given their immediate availability, phonoelectrocardiography STIs' parameters and particularly EMAT/LVET ratio could have an important role in the diagnosis approach of HF in patients with undifferentiated dyspnea in the ED.

Hamdi Boubaker,1,2 Mohamed Habib Grissa,1,2 Kaouther Beltaief,1,2 Zohra Dridi,3 Mohamed Fadhel Najjar,4 Wahid Bouida,1,2 Riadh Boukef,5 Soudani Marghli,6 Semir Nouira1,2 1Department of Emergency, Fattouma Bourguiba University Hospital, 2Research Laboratory (LR12SP18), University of Monastir, 3Department of Cardiology, 4Department of Biochemistry, Fattouma Bourguiba University Hospital, Monastir, 5Department of Emergency, Sahloul University Hospital, Sousse, 6Department of Emergency, Tahar Sfar University Hospital, Mahdia, Tunisia Background: The goal of this study was to determine the value of systolic time intervals and their change during Valsalva maneuver (VM) in the diagnosis of left ventricular dysfunction (LVD) in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).Methods: We included 166 patients admitted to the emergency department for AECOPD. Measurement of systolic time intervals included electromechanical activation time (EMAT), left ventricular ejection time (LVET), and EMAT/LVET ratio. These were performed at baseline and during the first strain phase of the VM using a computerized phonoelectrocardiographic method. The diagnosis of LVD was determined on the basis of clinical examination, echocardiography, and brain natriuretic peptide. The values of systolic time intervals were compared between patients with and without LVD; their diagnostic performance was assessed using the area under receiver operating characteristic (ROC) curve.Results: Patients with LVD (n=95) had a significantly higher EMAT and lower LVET and EMAT/LVET ratio compared to patients without LVD (n=71); the area under ROC curve was 0.79, 0.88, and 0.90, respectively, for EMAT, LVET, and EMAT/LVET ratio. All baseline systolic time intervals changed significantly during VM in patients without LVD but they did not change in patients with LVD. The area under ROC curve increased to 0.84 and 0.93,­respectively, for EMAT and EMAT/LVET ratio but did not change for LVET.Conclusion: Simple and noninvasive measurements of systolic time intervals combined with VM could be helpful to detect or rule out LVD in patients admitted to the emergency room for COPD excacerbation. The EMAT/LVET ratio seems to have the best diagnostic value. Keywords: chronic obstructive pulmonary disease, exacerbation, systolic time intervals, Valsalva maneuver&nbsp

Background: Urbanization and adoption of new diet and lifestyles had increased the cardiovascular risk factor (CVRF) rate and therefore, acute coronary syndrome (ACS) in developing countries such as Tunisia. We aimed at determining ACS prevalence among a sample of Tunisian patients with chest pain, at establishing the standardized incidence rate (SIR) of ACS, and at quantifying the relationship between ASC and CVRF in this population. Methods: We studied 3158 patients admitted to a chest pain unit for non-traumatic chest pain collected in Emergency Data from January 2012 to December 2014. For all patients, the data were collected using a standardized form. We performed univariate rather than multivariate logistic regression analyses to identify age and gender-related CVRF in ACS. Linear interpolation was used for curve estimation. Results: 707 (22.3%) chest pain patients were classified as ACS. The age-SIR per 10 −5 personyear (PY) was 85.7; it was 112.6 in men and 45.3 in women. Eighty one percent of patient with ACS cumulated 2 CVRF and more. The highest odds ratio were 2.00 (95% CI 1.64–2.44) for diabetes and 1.81 (95% CI 1.50–2.18) for active smoking. ACS in elderly patients was significantly associated with active smoking (OR: 2.36), diabetes (OR: 1.72) and personal ACS history (OR: 1.71). We found a significant and very high linear relation between the number of CVRF and ACS odds ratio (R 2 =0.958). Conclusion: Our results showed that the incidence of ACS in a Tunisian population is not very different from what is observed in developed countries; with a close relation with CVRF especially diabetes and smoking.

Objectives We aim to determine the benefit of two different doses magnesium sulfate (MgSO4 ) compared to placebo in rate control of rapid atrial fibrillation (AF) managed in the emergency department (ED). Methods We undertook a randomized, controlled, double-blind clinical trial in three university hospital EDs between August 2009 and December 2014. Patients > 18 years with rapid AF (>120 beats/min) were enrolled and randomized to 9 g of intravenous MgSO4 (high-dose group, n = 153), 4.5 g of intravenous MgSO4 (low-dose group, n = 148), or serum saline infusion (placebo group, n = 149), given in addition to atrioventricular (AV) nodal blocking agents. The primary outcome was the reduction of baseline ventricular rate (VR) to 90 beats/min or less or reduction of VR by 20% or greater from baseline (therapeutic response). Secondary outcome included resolution time (defined as the elapsed time from start of treatment to therapeutic response), sinus rhythm conversion rate, and adverse events within the first 24 hours. Results At 4 hours, therapeutic response rate was higher in low- and high-MgSO4 groups compared to placebo group; the absolute differences were, respectively, 20.5% (risk ratio [RR] = 2.31, 95% confidence interval [CI] = 1.45-3.69) and +15.8% (RR = 1.89, 95% CI = 1.20-2.99). At 24 hours, compared to placebo group, therapeutic response difference was +14.1% (RR = 9.74, 95% CI = 2.87-17.05) with low-dose MgSO4 and +10.3% (RR = 3.22, 95% CI = 1.45-7.17) with high-dose MgSO4 . The lowest resolution time was observed in the low-dose MgSO4 group (5.2 ± 2 hours) compared to 6.1 ± 1.9 hours in the high-dose MgSO4 group and 8.4 ± 2.5 hours in the placebo group. Rhythm control rate at 24 hours was significantly higher in the low-dose MgSO4 group (22.9%) compared to the high-dose MgSO4 group (13.0%, p = 0.03) and the placebo group (10.7%). Adverse effects were minor and significantly more frequent with high-dose MgSO4 . Conclusions Intravenous MgSO4 appears to have a synergistic effect when combined with other AV nodal blockers resulting in improved rate control. Similar efficacy was observed with 4.5 and 9 g of MgSO4 but a dose of 9 g was associated with more side effects.

The Thrombolysis in Myocardial Infarction (TIMI) and the Global Registry in Acute Coronary Events (GRACE) scores were largely evaluated and validated in stratifying risk of cardiovascular events in patients with chest pain and acute coronary syndrome. Our objective was to compare these 2 scores in predicting outcome in emergency department (ED) patients with undifferentiated chest pain.This was a prospective cohort study including patients presenting to 4 EDs with chest pain with nondiagnostic or normal ECG. For all included patients (n = 3125), TIMI and GRACE scores were calculated. Follow-up was conducted at 30-day and 1-year post-ED index admission to identify major adverse events. Main outcome included all cause mortality, acute coronary syndrome, and coronary non-ED planned revascularization. Prognostic performance of the scores was assessed by the receiver operating characteristic (ROC) curves.We reported 285 (9.1%) major adverse events at 30 days and 436 (13.9%) at 1 year. In patients with low TIMI (≤2) and GRACE (109) scores, a significant proportion had major adverse events at 30 days (5% and 7.5%, respectively) and 1 year (7.9% and 12.9%, respectively). Area under ROC curve at 30 days was 0.66 (95% confidence interval [CI], 0.62-0.71) vs 0.57 (95% CI, 0.53-0.62), respectively, for TIMI and GRACE scores. At 1 year, the area under ROC was 0.67 (95% CI, 0.62-0.71) and 0.65 (95% CI, 0.60-0.70), respectively, for TIMI and GRACE scores.The TIMI and GRACE scores are not valid in short- and long-term risk stratification in our chest pain patients.

Background A number of factors may offset the cardioprotective effects of glucose‐insulin‐potassium (GIK) on outcome of patients with acute coronary syndrome, such as hyperglycemia induced by this cocktail infusion. We performed a study to evaluate the effect of intensive insulin therapy in association with GIK on 1‐year outcome in patients hospitalized for acute coronary syndrome. Methods and Results In a randomized prospective controlled trial we included 772 patients with non–ST‐segment elevation acute coronary syndrome. Patients were randomized into 3 groups: GIKI 2 group, who received GIK with intensive insulin therapy for 24 hours; GIK group, who received GIK with nonintensive insulin therapy; and control group, who received usual care. The primary outcome criteria were the rates of major cardiovascular events combining death, reinfarction, and stroke rate at 1 year. In addition, we measured platelet function assay‐100 and plasminogen activator inhibitor‐1 at admission and 24 hours later. Based on an intention‐to‐treat analysis, major cardiovascular events at 1 year was 12.8% in the GIKI 2 group, 15.5% in the GIK group, and 20.5% in the placebo group; the difference was significant between the GIK 2 and control groups ( P =0.01). Platelet function assay‐100 at 24 hours decreased significantly from baseline in the control group but not in the GIKI 2 group. Plasminogen activator inhibitor‐1 decreased significantly in the GIKI 2 group but significantly increased in the control group. Minor hypoglycemic events were more frequent in the GIKI 2 group compared with other groups. Conclusions GIKI 2 led to improvement of 1‐year outcome rates in patients with non–ST‐segment elevation acute coronary syndrome. This beneficial effect was associated with a decrease in platelet reactivity and an increase on fibrinolysis tests. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00965406.

Data on the effect of fasting on coronary disease are rare and controversial. The aim of our study was to investigate the influence of Ramadan on the prevalence of acute coronary syndrome among chest pain patients in the emergency department of Monastir.It was a prospective study, performed in the emergency department of Fattouma Bourguiba University Hospital of Monastir, during the 3 months before, during and after Ramadan from 2012 to 2014. We included all patients with non-traumatic chest pain during the study period. Data were collected using a standardized form. The uniformity chi 2 test, ANOVA test, Kruskal-Wallis test were performed at the 5% level. Binary logistic regression model was used for multivariate analysis.The SCA prevalence was 17% a month before Ramadan, 22% during Ramadan and 28% one month after Ramadan (p = 0.007). According to the results of the multivariate analysis, the period of Ramadan is not associated with increase of risk of SCA whereas the risk doubles after Ramadan in all group (p = 0.001). In subgroups analysis, the period of R was associated with an amplification of risk in men aged more than 55 years and women older than 65 years (OR: 2.1; p = 0.020) and among subjects with hypertension (OR: 2.4, p = 0.007). Ramadan and Shawwal were not associated with an increase of risk among subjects without CVX risk factor.We have demonstrated that the risk of SCA has increased in Ramadan only among the elderly and patient with hypertension. The increased risk in Shawwal can be explained by the lifting of dietary restriction.

There is evidence that diet and variation in lipid metabolism can influence blood coagulation, but little is known about the effect of Ramadan fasting on plasmatic coagulation pattern. We investigated the effect of Ramadan fasting on thrombin generation (TG) in patients with cardiovascular disease (CVD) risks, and we aimed to assess the effect of lipid profile on TG parameters. The study was conducted in 36 adults having at least 2 CVD risks and in 30 healthy controls. Coagulation pattern was assessed by both classical clotting times and TG test. A complete lipid profile was performed simultaneously. Patients were invited 2 times: 1 week before Ramadan and during the last week of the Ramadan. The TG parameters were not different in patients with CVD risks compared to healthy controls. Fasting had no effect on plasmatic coagulation parameters and on TG profile. Individual analysis of the mean rate index (MRI) of TG revealed 3 groups: group 1 with no modification of MRI, group 2 with a significant increase in MRI (81.64 nM/min vs 136.07 nM/min; P < .001), and group 3 with a significant decrease in MRI (125.27 nM/min vs 73.18 nM/min; P = .001). Only in group 2, a significant increase was observed in total cholesterol and low-density lipoprotein cholesterol. Changes in lipid profile during Ramadan fasting did not influence the global coagulation pattern in patients with CVD risks. Whereas, a significant increase in the propagation phase of TG was associated with a significant increase in cholesterol levels, which was not found with the other TG parameters.

Activity of the renin-angiotensin Aldosterone system is increased in patients with heart failure (HF). The Angiotensinogen gene and specifically M235T polymorphism has been linked to susceptibility to hypertension, coronary heart disease and atrial fibrillation. Its role in heart failure is not yet sufficiently demonstrated. The aim of the present study was to assess the association between rs699 (M235T) polymorphism and heart failure in terms of diagnosis and prognosis. We included all patients over 20 years old consulting in the Emergency Department for acute dyspnea. According to the results of the B-type natriuretic peptide (BNP level), patients were divided into two groups: HF and non-HF group. DNA study was performed for all subjects and their genotypes were identified as TT, CT or CC. Mortality was followed for one year. We included 234 patients. We found the diagnosis of HF in 73 patients out of 160 (45%). Our results showed that the frequency of the T allele was higher in HF group patients than in non-HF group (69% vs. 33%, P

Background Our aim was to compare the efficacy and safety of intravenous (IV) titrated morphine with nebulized morphine given at 2 different doses in severe traumatic pain. Methods In a prospective, randomized, controlled double-blind study, we included 300 patients with severe traumatic pain. They were assigned to 3 groups: Neb10 group received 1 nebulization of 10-mg morphine; Neb20 group received 1 nebulization of 20-mg morphine, repeated every 10 minutes with a maximum of 3 nebulizations; and the IV morphine group received 2-mg IV morphine repeated every 5 minutes until pain relief. Visual analog scale was monitored at baseline, 5, 10, 15, 20, 25, 30, and 60 minutes after the start of drug administration. Treatment success was defined by the percentage of patients in whom visual analog scale decreased greater than or equal to 50% of its baseline value. When this end point was not reached, rescue morphine was administered. Pain resolution time was defined by the elapsed time between the start of the protocol and the reach of treatment success criteria. Results Success rate was significantly better at 97% (95% confidence interval [CI], 93-100) for Neb20 group compared to Neb10 group (81% [95% CI, 73-89]) and IV morphine group (79% [95% CI, 67-84]). The lowest resolution time was observed in Neb20 group (20 minutes [95% CI, 18-21]). Side effects were minor and significantly lower in both nebulization groups compared to IV morphine group. Conclusions Nebulized morphine using boluses of 10 mg has similar efficacy and better safety than IV titrated morphine in patients with severe posttraumatic pain. Increasing nebulized boluses to 20 mg increases the effectiveness without increasing side effects.

Our aim is to compare a new generic version of enoxaparin (Enoxa®) with the parent brand (Lovenox®). We included patients with acute coronary syndrome (ACS) for the clinical study and healthy volunteers for the experimental study. ACS patients randomly assigned to receive a bolus of Enoxa® (n=86) or Lovenox® (n=83) and serum anti-Xa activity was measured 4 hours thereafter. For experimental study, blood from healthy volunteers was used to compare the effect of both formulations on thrombin generation in citrated platelet-poor plasma (PPP). The half maximal inhibitory concentration of the drug (IC50) that is required to inhibit 50% in-vitro thrombin generation parameters, mean rate index (MRI) and endogenous thrombin potential (ETP). Both IC50 MRI and IC50 ETP were calculated in PPP. In ACS patients, serum anti-Xa activity was found not different between Enoxa® and Lovenox®. Median anti Xa activity measured 4 hours after the initial bolus was 0.39 IU anti-Xa/ml [95 % CI 0.31-0.53] and 0.34 IU anti-Xa/ml [95% CI 0.27-0.53], for the Enoxa® group and Lovenox® group respectively. No difference in major cardiovascular events was observed during hospital stay. In healthy volunteers, IC50 MRI and IC50 ETP were similar between Lovenox® and Enoxa® in PPP [(2.5 μg/ml ± 0.2 μg/ml) versus (2.3 μg/ml ± 0.1μg/ml) respectively for IC50 MRI; (p=0.2)] and [(4.8 μg/ml ± 0.8 μg/ml) versus (4.1 μg/ml ± 0.1 μg/ml) respectively for IC50 ETP; (p=0.2)]. With both formulations, anti-Xa activity and anti-Xa/anti-IIa ratio were similar. The generic enoxaparin Enoxa® met the main regulatory criteria of bioequivalence with the branded product.

Summary What is known and Objective: Ranitidine is a generally well-tolerated drug, and serious side effects are rare. However, ranitidine-induced anaphylaxis has been reported on rare occasions. We report on such a case and review other cases reported in the literature. Case summary: A 36-year-old man with no history of other medications, illnesses or allergic diseases, especially to drugs, consulted our emergency department because of renal colic and epigastric discomfort. He was given 50 mg of ranitidine as a slow intravenous bolus and 20 mg of piroxicam intramuscularly. Within the first minute, the patient developed a cold sweat, trembling, dyspnoea and deterioration of his consciousness. The condition was considered as an anaphylactic shock, and cardiopulmonary resuscitation and inotropic support were immediately commenced. Two days later, he was weaned off the ventilator as he was haemodynamically stable. He was discharged after 7 days. Four weeks later, skin prick tests to ranitidine and piroxicam were performed on the forearm of the patient. He reacted strongly to ranitidine about 10 min later but not to piroxicam. To assess cross-reactivity to other H2- and H1-receptor antagonists in our patient, we subsequently performed prick tests to famotidine, cimetidine and desloratadine and all were negative. What is new and Conclusion: We re-emphasize a potentially serious, albeit very rare, adverse effect of ranitidine and summarize other reported cases. This case demonstrates that commonly used, generally safe drugs may on occasions cause serious adverse effects.

Introduction Guidelines dealing with severe sepsis and septic shock mostly rely on randomized controlled trials (RCTs) to ensure the best standards of care for patients. However, patients included in high-quality studies may differ from the routine population and alter external validity of recommendations. We aimed to determine to what extent non-inclusion criteria of RCTs dealing with severe sepsis and septic shock may affect application of their conclusions in routine care. Methods In a first step, the MEDLINE database was searched for RCTs treating severe sepsis and septic shock patients between 1992 and 2008, and non-inclusion criteria for these studies were abstracted. Two reviewers independently evaluated the articles, which were checked by a third reviewer. We extracted data on the study design, main intervention, primary endpoint, criteria for inclusion, and criteria for non-inclusion. In a second step, the distribution of the non-inclusion criteria was observed in a prospective multicenter cohort of severe sepsis and septic shock patients (Cub-Rea network, 1992 to 2008). Results We identified 96 articles out of 7,012 citations that met the screening criteria. Congestive heart failure (35%) and cancer (30%) were frequent exclusion criteria in selected studies, as well as other frequent disorders such as gastrointestinal and liver diseases and all causes of immune suppression. Of the 67,717 patients with severe sepsis and septic shock in the Cub-Rea database, 40,325 (60%) experienced at least one of the main exclusion criteria, including 11% of congestive heart failure patients and 11% of cancer patients. In addition, we observed a significant trend for increasing number of patients with these criteria along time. Conclusion Current exclusion criteria for RCTs dealing with severe sepsis and septic shock excluded most patients encountered in daily practice and limit external validity of the results of high-quality studies.

OBJECTIVE The goal of this study was to compare the prediction performance of two anatomic scales, the Injury Severity Scale (ISS) and the New Injury Severity Scale (NISS), with two physiologic scales, the Revised Trauma Scale (RTS) and the Simplified Acute Physiology Scale II (SAPS II), in trauma patients. DESIGN Prospective study carried out over a 16-month period. SETTING Emergency department of a teaching hospital. PATIENTS Hospitalized victims of trauma up to 14 years of age. INTERVENTIONS The primary endpoint was the survival status at hospital discharge; the secondary outcome was need for ICU admission. Model discrimination was evaluated by the area under the receiver-operating characteristic curve and model calibration was evaluated using the Hosmer-Lemeshow goodness-of-fit statistic. MEASUREMENTS AND MAIN RESULTS A total of 1136 patients, with an average age of 37.6 years, fulfilled the inclusion criteria. The mortality rate was 4.5%. The combined rate of hospital death and ICU admission was 17.3%. The ISS and the NISS showed excellent discriminative power for mortality prediction (AUC 0.94 and 0.93, respectively) and ICU admission decision (0.91 and 0.89, respectively), and a good calibration. The SAPS II and the RTS showed lower discriminative power. Combining ISS or NISS with SAPS II did not improve significantly the predictive performance of each scale alone. CONCLUSION Both ISS and NISS showed better predictive severity performance compared with RTS and SAPS II in trauma patients. The combination of anatomic scales with physiologic ones did not improve the prediction performance of each scale considered alone.

Treatment with short-acting β2-agonists for exacerbations of chronic obstructive pulmonary disease (COPD) results in clinical improvement. It has not been established whether combining short-acting β2-agonists to other bronchodilators is more effective than β2-agonists alone. We conducted a study in patients presenting to the emergency department with exacerbation of COPD. They were randomized to receive nebulized ipratropium bromide (IB group; n = 62) or combined nebulized and intravenous bolus of magnesium sulfate (MgSO4 group; n = 62). All nebulized drugs were administered at 30-minute intervals for 2 hours. Primary outcome included hospital admission, endotracheal intubation, and hospital death rates. Secondary outcome measures were improvement in peak expiratory flow, dyspnea score, and arterial blood gas changes within the first 3 hours. There were no significant differences in primary outcome between MgSO4 and IB groups. Patients given IB average 32 L greater improvement in peak expiratory flow rate compared with magnesium sulfate (95% confidence interval, 19-43 L) at 180 minutes. Simultaneously, there was a significant reduction in PaCO2 compared with baseline values in IB group but not in MgSO4 group. There was a statistically nonsignificant trend toward a decrease in dyspnea score in both groups although adverse events were similar. Although the improvement in peak expiratory flow rate and arterial blood gas favored nebulized IB over magnesium sulfate, there was a nonsignificant difference between both drugs with regard to hospital admission, intubation, and hospital death rates in patients with COPD treated in the emergency department for acute exacerbation.

Study objective The New Orleans Criteria and the Canadian CT Head Rule have been developed to decrease the number of normal computed tomography (CT) results in mild head injury. We compare the performance of both decision rules for indentifying patients with intracranial traumatic lesions and those who require an urgent neurosurgical intervention after mild head injury. Methods This was an observational cohort study performed between 2008 and 2011 on patients with mild head injury who were aged 10 years or older. We collected prospectively clinical head CT scan findings and outcome. Primary outcome was need for neurosurgical intervention, defined as either death or craniotomy, or the need of intubation within 15 days of the traumatic event. Secondary outcome was the presence of traumatic lesions on head CT scan. New Orleans Criteria and Canadian CT Head Rule decision rules were compared by using sensitivity specifications and positive and negative predictive value. Results We enrolled 1,582 patients. Neurosurgical intervention was performed in 34 patients (2.1%) and positive CT findings were demonstrated in 218 patients (13.8%). Sensitivity and specificity for need for neurosurgical intervention were 100% (95% confidence interval [CI] 90% to 100%) and 60% (95% CI 44% to 76%) for the Canadian CT Head Rule and 82% (95% CI 69% to 95%) and 26% (95% CI 24% to 28%) for the New Orleans Criteria. Negative predictive values for the abovementioned clinical decision rules were 100% and 99% and positive values were 5% and 2%, respectively, for the Canadian CT Head Rule and New Orleans Criteria. Sensitivity and specificity for clinical significant head CT findings were 95% (95% CI 92% to 98%) and 65% (95% CI 62% to 68%) for the Canadian CT Head Rule and 86% (95% CI 81% to 91%) and 28% (95% CI 26% to 30%) for the New Orleans Criteria. A similar trend of results was found in the subgroup of patients with a Glasgow Coma Scale score of 15. Conclusion For patients with mild head injury, the Canadian CT Head Rule had higher sensitivity than the New Orleans Criteria, with higher negative predictive value. The question of whether the use of the Canadian CT Head Rule would have a greater influence on head CT scan reduction requires confirmation in real clinical practice.