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Summary Background Intravenous saline is recommended in clinical practice guidelines as the cornerstone for preventing contrast-induced nephropathy in patients with compromised renal function. However, clinical-effectiveness and cost-effectiveness of this prophylactic hydration treatment in protecting renal function has not been adequately studied in the population targeted by the guidelines, against a group receiving no prophylaxis. This was the aim of the AMACING trial. Methods AMACING is a prospective, randomised, phase 3, parallel-group, open-label, non-inferiority trial of patients at risk of contrast-induced nephropathy according to current guidelines. High-risk patients (with an estimated glomerular filtration rate [eGFR] of 30–59 mL per min/1·73 m 2 ) aged 18 years and older, undergoing an elective procedure requiring iodinated contrast material administration at Maastricht University Medical Centre, the Netherlands, were randomly assigned (1:1) to receive intravenous 0·9% NaCl or no prophylaxis. We excluded patients with eGFR lower than 30 mL per min/1·73 m 2 , previous dialysis, or no referral for intravenous hydration. Randomisation was stratified by predefined risk factors. The primary outcome was incidence of contrast-induced nephropathy, defined as an increase in serum creatinine from baseline of more than 25% or 44 μmol/L within 2–6 days of contrast exposure, and cost-effectiveness of no prophylaxis compared with intravenous hydration in the prevention of contrast-induced nephropathy. We measured serum creatinine immediately before, 2–6 days, and 26–35 days after contrast-material exposure. Laboratory personnel were masked to treatment allocation. Adverse events and use of resources were systematically recorded. The non-inferiority margin was set at 2·1%. Both intention-to-treat and per-protocol analyses were done. This trial is registered with ClinicalTrials.gov, number NCT02106234. Findings Between June 17, 2014, and July 17, 2016, 660 consecutive patients were randomly assigned to receive no prophylaxis (n=332) or intravenous hydration (n=328). 2–6 day serum creatinine was available for 307 (92%) of 332 patients in the no prophylaxis group and 296 (90%) of 328 patients in the intravenous hydration group. Contrast-induced nephropathy was recorded in eight (2·6%) of 307 non-hydrated patients and in eight (2·7%) of 296 hydrated patients. The absolute difference (no hydration vs hydration) was −0·10% (one-sided 95% CI −2·25 to 2·06; one-tailed p=0·4710). No hydration was cost-saving relative to hydration. No haemodialysis or related deaths occurred within 35 days. 18 (5·5%) of 328 patients had complications associated with intravenous hydration. Interpretation We found no prophylaxis to be non-inferior and cost-saving in preventing contrast-induced nephropathy compared with intravenous hydration according to current clinical practice guidelines. Funding Stichting de Weijerhorst.

We thank Vikram Raje and Akira Sato and colleagues for their interest in our work. To put the AMACING trial into perspective, the guideline on contrast induced nephropathy (CIN) is one of ten measures to increase patient safety in the Netherlands. Since their introduction and to date, the ten measures have been imposed on hospitals quite strictly, and compliance to these is part of the annual hospital quality assessment carried out by government instances. However, the intravenous hydration to prevent CIN was introduced without its effect having been proven, and its implementation incurs risk of clinical complications as well as increased health care costs.

Background & Aims: Previous studies reported a severely impaired energy balance in COPD patients during the first days of an acute exacerbation, mainly due to a decreased energy and protein intake. The aim of the study was to investigate the feasibility and effectiveness of energy- and protein-rich nutritional supplements during hospitalization for an acute exacerbation in nutritionally depleted COPD patients. Methods: In a randomized double-blind, placebo-controlled two-center trial, 56 COPD patients were randomized and 47 patients completed the study. Nutritional intervention consisted of 3×125 ml (2.38 MJ/day) and the placebo group received similar amounts of a non-caloric fluid. Medical therapy and dietetic consultation were standardized and dietary intake was measured daily. Body composition, respiratory and skeletal muscle strength, lung function and symptoms were measured on admission and on days 4 and 8 of hospitalization. Results: Forty-seven percent of the patients had experienced recent involuntary weight loss prior to admission. The degree of weight loss was inversely related to resting arterial oxygen tension (r=0.31; P Conclusions: Oral nutritional supplementation during hospitalization for an acute exacerbation is feasible in nutritionally depleted COPD patients and does not interfere with normal dietary intake.

In this study, we investigated the influence of an acute disease exacerbation on the nutritional and metabolic status of patients with chronic obstructive pulmonary disease (COPD). The study group consisted of 23 patients acutely admitted to the hospital for standardized medical treatment. Dietary intake (dietary records and diet history), resting energy expenditure (ventilated hood), body composition (bioelectrical impedance spectroscopy) and disease symptoms (visual analogue scale) were assessed on admission, daily throughout the hospitalization period, at discharge and 3 months thereafter in stable clinical condition. Dietary intake, since aggravation of disease symptoms, prior to admission, (5,640+/-2,671 kJ) was significantly lower than habitual intake (7,863+/-2,005 kJ). The balance between dietary intake with measured resting energy expenditure and estimated diet-induced thermogenesis was severely impaired during the first 3 days of hospitalization, stabilizing thereafter to 145+/-24% at discharge. Resting energy expenditure decreased from 6,812+/-900 kJ (123+/-11%) on admission to 6,196+/-795 kJ (113+/-14%) at discharge (p

Energy balance in depleted ambulatory patients with chronic obstructive pulmonary disease: the effect of physical activity and oral nutritional supplementation.Goris AH, Vermeeren MA, Wouters EF, Schols AM, Westerterp KR.Department of Human Biology, Maastricht University, Maastricht, The Netherlands.Patients with chronic obstructive pulmonary disease (COPD) often suffer from weight loss. The aim of the present study was to gain insight into the energy balance of depleted ambulatory COPD patients, in relation to their habitual level of physical activity and consumption of oral nutritional supplements. Clinically stable and weight-stable patients (n 20; BMI 19.8+/- SD 2.0 kg/m2) were studied 1 and 3 months after rehabilitation or recovery in the clinic and were at random assigned to a control or intervention group with regard to nutritional supplementation. Energy intake was measured with a 7 d food record. Energy expenditure was estimated from a simultaneous 7 d assessment of physical activity with a tri-axial accelerometer for movement registration in combination with measured BMR. Body mass was measured at several time points. The body mass remained stable in both groups after 1 or 3 months and mean energy balances were comparable for both groups. The mean body-mass change between month 1 and 3 was negatively related to the mean physical activity level (r -0.49; P=0.03). Weight change over the 3 months was negatively associated with the physical activity level. These results suggest that knowledge about the individual physical activity level is necessary for the estimation of the energy need of the COPD patient.