Table 3.
Randomized controlled trials registered on clinicaltrials.gov of nutrition studies in critically ill adults
| NCT number | Title | Recruitment | Interventions | Sponsor/collaborators | Enrollment | Start date | Completion date | Acronym |
|---|---|---|---|---|---|---|---|---|
| Evaluation of energy expenditure and monitoring of nutritional effects in different phases of critical illness and across patients with different nutritional risks | ||||||||
| NCT02897713 | Feasibility, safety, and outcomes of intensive enteral nutrition in patients with mechanical ventilation | Recruiting | Intensive enteral nutrition, routine enteral nutrition | Shanghai Zhongshan Hospital Shanghai 6th People’s Hospital Shanghai Tongji Hospital, Tongji University School of Medicine Shanghai 10th People’s Hospital Shanghai Jinshan Hospital Shanghai Minhang Central Hospital Renji Hospital Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Shanghai East Hospital Xuhui Central Hospital, Shanghai Tongren Hospital, Shanghai |
400 | Nov-16 | Mar-18 | – |
| NCT02022813 | Impact of supplemental parenteral nutrition in ICU patients on metabolic, inflammatory, and immune responses | Recruiting | Supplemental parenteral nutrition (SPN) | Centre Hospitalier Universitaire Vaudois University of Geneva, Switzerland |
30 | Apr-14 | Dec-16 | SPN2 |
| NCT02306746 | The augmented versus routine approach to giving energy trial | Recruiting | TARGET protocol EN 1.5 kcal/ml, TARGET protocol EN 1.0 kcal/ml |
Australian and New Zealand Intensive Care Research Centre | 4000 | Jun-16 | Apr-18 | TARGET |
| Timing and administration of enteral and parenteral nutrition | ||||||||
| NCT02358512 | Intermittent versus continuous feeding in ICU patients | Recruiting | Enteral feeding | Guy’s and St Thomas’ NHS Foundation Trust University College, London The Whittington Hospital NHS Trust |
116 | Feb-15 | Dec-17 | – |
| NCT02159456 | Continuous versus intermittent enteral feeding in critically ill patients | Recruiting | Continuous enteral feeding via infusion pump, intermittent enteral feeding via gravity-based infusion | Seoul National University Hospital | 70 | May-14 | Apr-17 | – |
| NCT02853799 | Comparison of the effects of intermittent and continuous enteral feeding on glucose-insulin dynamics in critically ill medical patients | Not yet recruiting | Osmolite 1.2 cal/ml enteral feeds | San Antonio Military Medical Center | 20 | Aug-16 | Oct-17 | – |
| Substrate requirements: proteins and carbohydrates | ||||||||
| NCT01934595 | Optimal protein supplementation for critically ill patients | Recruiting | Beneprotein | University of Oklahoma | 100 | Sep-13 | Sep-16 | – |
| NCT02755155 | Optimization of therapeutic human serum albumin infusion in selected critically ill patients | Not yet recruiting | Human serum albumin infusion 4%, human serum albumin infusion 20% | University Hospital, Strasbourg, France | 550 | Sep-16 | May-19 | AlbAlsace |
| NCT02503527 | Efficacy and safety study of a low-carbohydrate tube feed in critically ill patients under insulin therapy | Recruiting | Diben 1.5 kcal HP, Fresubin HP Energy Fibre (1.5 kcal) | Fresenius Kabi OE Clinical Trial Center (KKS) Universität Innsbruck International Medical Research-Partner GmbH dsh statistical services GmbH |
40 | Sep-15 | Sep-17 | – |
| NCT02106624 | A trial to assess the effect of high nitrogen intake in critically ill patients | Recruiting | Nitrogen supply | Shanghai Zhongshan Hospital | 80 | Mar-15 | Aug-17 | – |
| NCT02678325 | The basal enteral high protein study | Recruiting | Standardized high protein enteral nutrition, standardized normal protein enteral nutrition | University Hospital, Basel, Switzerland | 90 | May-16 | Oct-16 | – |
| NCT02584907 | Fat based enteral nutrition for blood glucose control in ICU | Recruiting | High fat enteral nutrition | Shahid Beheshti University | 88 | Oct-15 | Jan-17 | – |
| NCT02763553 | Does a ketogenic diet cause ketosis in patients on intensive care? | Not yet recruiting | Ketogenic feed, standard feed | University Hospitals Bristol NHS Foundation Trust | 10 | Dec-16 | Mar-17 | – |
| NCT01833624 | Efficiency of a small-peptide enteral feeding formula compared to a whole-protein formula | Recruiting | Peptamen® AF, Sondalis® HP | Centre Hospitalier Universitaire de Besancon Nestlé© Foundation |
206 | Jun-12 | Aug-17 | NUTRI_REA |
| NCT02865408 | Amino acid nutrition in the critically ill | Not yet recruiting | Peptamen 1.5% via enteral, Prosol 20% IV to 1.75 g/kg/day, Prosol 20% IV to 2.5 g/kg/day | McGill University Health Center | 30 | Sep-16 | Sep-19 | AA-ICU |
| Nutrition and functional recovery | ||||||||
| NCT02509520 | Assessing the effects of exercise, protein, and electric stimulation on intensive care unit patients outcomes | Recruiting | MPR and high protein supplement (HPRO), MPR and neuromusc electric stimulation (NMES)|, MPR and NMES and HPRO | University of Maryland | 60 | May-15 | Jul-17 | ExPrEs |
| NCT02773771 | Strategies to reduce organic muscle atrophy in the intensive care unit | Not yet recruiting | Beta-hydroxy-beta-methylbutyrate, Placebo, Vital HP® | Massachusetts General Hospital | 60 | Jan-17 | Jan-19 | STROMA-ICU |
| NCT02822170 | Nutrition and exercise in critical illness: a randomized trial of combined cycle ergometry and amino acids in the ICU | Not yet recruiting | Amino acid supplementation plus early in-bed cycle ergometry exercise | Clinical Evaluation Research Unit at Kingston General Hospital | 142 | May 2017 | May 2021 | NEXIS Trial |
| Management of intestinal and gastric feeding intolerance | ||||||||
| NCT02528760 | To determine the role of prokinetics in feed intolerance in critically ill cirrhosis | Recruiting | Metaclopramide, erythromycin, placebo | Institute of Liver and Biliary Sciences, India | 162 | Sep-15 | Feb-17 | – |
| NCT01934192 | Nutritional adequacy therapeutic enhancement in the critically ill: a randomized double blind, placebo-controlled trial of the motilin receptor agonist GSK962040 | Finished recruiting | Novel motilin agonist vs. placebo | Clinical evaluation research unit at Kingston General Hospital | 150 | August 2013 | July 2016 | The NUTRIATE study |
| NCT02459275 | PEP uP protocol in surgical patients | Recruiting | PEP uP protocol | Clinical Evaluation Research Unit at Kingston General Hospital | 100 | Jul-15 | Sep-17 | – |
| NCT02609620 | Safety & initial efficacy of the LunGuard PFT Sys. on Enteral-Fed, sedated and mechanically ventilated patients peristaltic feeding tube | Not yet recruiting | Peristaltic feeding tube, ConvaTec levin duodenal tube | LunGuard Ltd. | 20 | Dec-15 | Oct-16 | PFT |
| NCT02705027 | Comparison of two endoscopically placed nasojejunal probes | Recruiting | Freka®-Trilumina versus Freka®-EasyIn | Ruhr University of Bochum | 64 | Aug-12 | Aug-16 | – |
| NCT02515123 | Promotion of esophageal motility to prevent regurgitation and enhance nutrition intake in ICU patients | Recruiting | E-motion system, sham E-motion system | E-Motion Medical Ltd. Clinical Evaluation Research Unit at Kingston General Hospital |
140 | Feb-16 | Dec-17 | PROPEL |
| Immune-modulating nutrition | ||||||||
| NCT02738762 | Glutamine supplementation | Not yet recruiting | Glutamine supplementation | Medical Centre Leeuwarden | 80 | Jun-16 | Mar-17 | – |
| NCT01162928 | Parenteral nutrition with intravenous and oral fish oil for intensive care patients | Recruiting | Nutriflex Omega special + Oxepa, Nutriflex Lipid special + Pulmocare | B. Braun Melsungen AG | 100 | May-13 | Jan-18 | – |
| NCT02189538 | Effect of n-3 PUFA from fish in enteral nutrition of major burn patients | Recruiting | ω-3 PUFA, low fat enteral diet | Centro Nacional de Quemados, Uruguay | 100 | Jan-13 | Feb-17 | OmegaBurn |
| NCT02868827 | Cholecalciferol supplementation in critically ill patients with severe vitamin D deficiency | Not yet recruiting | Cholecalciferol, milk (Nestle) | King Abdullah Medical City | 430 | Oct-16 | Dec-18 | – |
| NCT01704430 | Glutamine to improve outcomes in cardiac surgery | Recruiting | Glutamine, maltodextrin | University of Alberta | 100 | Sep-12 | Jul-16 | GLADIATOR |
| NCT02594579 | Effect of vitamin D3 supplementation on muscle mass in ICU patient | Not yet recruiting | Vitamin D3, placebo | Mahidol University | 40 | Oct-15 | Dec-16 | – |
| NCT00985205 | A randomized trial of ENtERal glutamine to minimize thermal injury | Recruiting | Enteral glutamine vs. placebo | Clinical Evaluation Research Unit at Kingston General Hospital | 2700 | Jul-15 | July 2021 | The RE_ENERGIZE trial |
| NCT02002247 | SodiUm SeleniTe administration IN cardiac surgery: a multicenter, randomized controlled trial of high-dose sodium-selenite administration in high-risk cardiac surgical patients |
Recruiting | High-dose intravenous Selenium vs. placebo | Clinical Evaluation Research Unit at Kingston General Hospital | 1400 | Oct-15 | October 2019 | SUSTAIN CSX®-trial |
| NCT02864017 | Immuno nutrition by l-citrulline for critically ill patients | Recruiting | Enteral nutrition, l-citrulline, placebo | Rennes University Hospital | 120 | Sep-16 | Oct-18 | Immunocitre |
| Others | ||||||||
| NCT01477320 | Enteral nutrition as stress ulcer prophylaxis in critically ill patients | Recruiting | Pantoprazole 40 mg IV daily and tube feed, placebo and tube feed | Abbott nutrition University of Louisville |
198 | Aug-13 | Oct-17 | – |
We searched for “open” “interventional” studies in “adults” and “seniors” on November 28, 2016 using the following search strategy: “nutrition” OR “feeding” OR “enteral feeding” OR “feed” OR “energy” OR “formula” OR “protein” OR “parenteral nutrition” | open studies | interventional studies | “critical illness” OR “mechanical ventilation” OR “inflammation” OR “intensive care” OR “intensive care unit” OR “critically ill” | adult, senior. The search revealed 58 studies. The results were evaluated manually and studies of other scopes (non-randomized, non-nutrition) were removed from the list