4 results on '"Parise, Diego"'
Search Results
2. Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial.
- Author
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von Groote T, Meersch M, Romagnoli S, Ostermann M, Ripollés-Melchor J, Schneider AG, Vandenberghe W, Monard C, De Rosa S, Cattin L, Rahmel T, Adamzik M, Parise D, Candela-Toha A, Haaker JG, Göbel U, Bernard A, Lumlertgul N, Fernández-Valdes-Bango P, Romero Bhathal I, Suarez-de-la-Rica A, Larmann J, Villa G, Spadaro S, Wulf H, Arndt C, Putensen C, García-Álvarez R, Brandenburger T, Siniscalchi A, Ellerkmann R, Espeter F, Porschen C, Sadjadi M, Saadat-Gilani K, Weiss R, Gerss J, Kellum J, and Zarbock A
- Subjects
- Humans, Prospective Studies, Biomarkers, Renal Replacement Therapy, Multicenter Studies as Topic, Tissue Inhibitor of Metalloproteinase-2 urine, Acute Kidney Injury etiology, Acute Kidney Injury prevention & control
- Abstract
Introduction: Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might reduce rate and severity of AKI after surgery. However, the effects of the care bundle in broader population of patients undergoing surgery require confirmation., Methods and Analysis: The BigpAK-2 trial is an international, randomised, controlled, multicentre trial. The trial aims to enrol 1302 patients undergoing major surgery who are subsequently admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases 2*insulin like growth factor binding protein 7 (TIMP-2)*IGFBP7)). Eligible patients will be randomised to receive either standard of care (control) or a KDIGO-based AKI care bundle (intervention). The primary endpoint is the incidence of moderate or severe AKI (stage 2 or 3) within 72 hours after surgery, according to the KDIGO 2012 criteria. Secondary endpoints include adherence to the KDIGO care bundle, occurrence and severity of any stage of AKI, change in biomarker values during 12 hours after initial measurement of (TIMP-2)*(IGFBP7), number of free days of mechanical ventilation and vasopressors, need for renal replacement therapy (RRT), duration of RRT, renal recovery, 30-day and 60-day mortality, intensive care unit length-of-stay and hospital length-of-stay and major adverse kidney events. An add-on study will investigate blood and urine samples from recruited patients for immunological functions and kidney damage., Ethics and Dissemination: The BigpAK-2 trial was approved by the Ethics Committee of the Medical Faculty of the University of Münster and subsequently by the corresponding Ethics Committee of the participating sites. A study amendment was approved subsequently. In the UK, the trial was adopted as an NIHR portfolio study. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research., Trial Registration Number: NCT04647396., Competing Interests: Competing interests: MM has received lecture fees from Biomériux, Baxter and Fresenius Medical Care as well as an unrestricted research grant from Baxter. AZ has received lecture and consultancy fees from Biomériux, Baxter, AM Pharma, Novartis, Guard Therapeutics, Paion, Bayer and Fresenius Medical Care. In addition, AZ received unrestricted research grants from Baxter, Biomériux, Fresenius and the Deutsche Forschungsgemeinschaft (German Research Foundation). JK is a paid consultant to Biomériux and is employed by Spectral Medical. SR received lecture fees from bioMerieux, Baxter and BBraun, as well as an unrestricted research grant from Baxter. SdR has received an educational grant from bioMerieux. MO has received research funding from bioMerieux. JG has received honoraria from TESARO, QUIRIS Healthcare, Ecker+Ecker, Dr August Wolff, Roche, University Clinics Schleswig-Holstein and RWTH Aachen University. AS has received consultancy fees from bioMerieux. All other authors have no conflict of interests to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
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3. Study protocol for an observational cohort evaluating incidence and clinical relevance of perioperative elevation of high-sensitivity troponin I and N-terminal pro-brain natriuretic peptide in patients undergoing lung resection.
- Author
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Alonso M, Popova E, Martin-Grande A, Pérez-Vélez J, Trujillo JC, Gajate L, de Miguel M, González-Tallada A, Martínez-Téllez E, Cladellas-Gutierrez E, Planas G, de Pablo A, Parise D, Candela-Toha A, and de Nadal M
- Subjects
- Humans, Biomarkers, Clinical Relevance, Cohort Studies, Incidence, Lung, Natriuretic Peptide, Brain, Observational Studies as Topic, Peptide Fragments, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications diagnosis, Predictive Value of Tests, Prospective Studies, Troponin T, Heart Diseases etiology, Troponin I
- Abstract
Introduction: Myocardial injury after non-cardiac surgery has been defined as myocardial injury due to ischaemia, with or without additional symptoms or ECG changes occurring during or within 30 days after non-cardiac surgery and mainly diagnosed based on elevated postoperative cardiac troponin (cTn) values. In patients undergoing thoracic surgery for lung resection, only postoperative cTn elevations are seemingly not enough as an independent predictor of cardiovascular complications. After lung resection, troponin elevations may be regulated by mechanisms other than myocardial ischaemia. The combination of perioperative natriuretic peptide measurement together with high-sensitivity cTns may help to identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection. We designed our cohort study to evaluate perioperative elevation of both high-sensitivity troponin I (hs-TnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients undergoing lung resection and to establish a risk score for major cardiovascular postoperative complications., Methods and Analysis: We will conduct a prospective, multicentre, observational cohort study, including 345 patients undergoing elective thoracic surgery for lung resection. Cardiac biomarkers such as hs-TnI and NT-proBNP will be measured preoperatively and at postoperatively on days 1 and 2. We will calculate a risk score for major cardiovascular postoperative complications based on both biomarkers' perioperative changes. All patients will be followed up for 30 days after surgery., Ethics and Dissemination: All participating centres were approved by the Ethics Research Committee. Written informed consent is required for all patients before inclusion. Results will be disseminated through publication in peer-reviewed journals and presentations at national or international conference meetings., Trial Registration Number: NCT04749212., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2022
- Full Text
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4. Predicting acute renal failure after cardiac surgery: external validation of two new clinical scores.
- Author
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Candela-Toha A, Elías-Martín E, Abraira V, Tenorio MT, Parise D, de Pablo A, Centella T, and Liaño F
- Subjects
- Acute Kidney Injury therapy, Calibration, Female, Humans, Male, Predictive Value of Tests, ROC Curve, Registries, Renal Replacement Therapy, Reproducibility of Results, Retrospective Studies, Risk Assessment, Risk Factors, Spain, Acute Kidney Injury diagnosis, Acute Kidney Injury etiology, Cardiac Surgical Procedures adverse effects, Health Status Indicators
- Abstract
Background and Objectives: Different scores to predict acute kidney injury after cardiac surgery have been developed recently. The purpose of this study was to validate externally two clinical scores developed at Cleveland and Toronto., Design, Setting, Participants, & Measurements: A retrospective analysis was conducted of a prospectively maintained database of all cardiac surgeries performed during a 5-yr period (2002 to 2006) at a University Hospital in Madrid, Spain. Acute kidney injury was defined as the need for renal replacement therapy. For evaluation of the performance of both models, discrimination and calibration were measured., Results: Frequency of acute kidney injury after cardiac surgery was 3.7% in the cohort used to validate the Cleveland score and 3.8% in the cohort used to validate the Toronto score. Discrimination of both models was excellent, with values for the areas under the receiving operator characteristics curves of 0.86 (95% confidence interval 0.81 to 0.9) and 0.82 (95% confidence interval 0.76 to 0.87), respectively. Calibration was poor, with underestimation of the risk for acute kidney injury except for patients within the very-low-risk category. The performance of both models clearly improved after recalibration., Conclusions: Both models were found to be very useful to discriminate between patients who will and will not develop acute kidney injury after cardiac surgery; however, before using the scores to estimate risk probabilities at a specific center, recalibration may be needed.
- Published
- 2008
- Full Text
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