Nutritional support belongs to the basic treatment bundles in critically ill patients with fundamental clinical significance on patients` mid- and long-term outcome. Several recent studies have led to considerable changes in our understanding of the metabolic response to critical illness and demonstrated that nutrition support is a complex subject, which needs an individualized treatment approach for different types of ICU patients.
Clinical nutrition and metabolic care include various aspects such as nutrition risk assessment, nutritional management (e.g. enteral, parenteral and combined nutrition strategies), monitoring of the metabolic response, measurement of caloric, protein, and micronutrient requirements & metabolism and evaluation of treatment strategies by adequate outcome functional measures. To clarify optimal strategies and to improve health outcomes, we aim to gather together interdisciplinary experts to identify patients who may benefit from nutrition support, when best to initiate nutrition support, and the potential use of pharmaco-nutrition to modulate the inflammatory response to surgical or divers inflammatory stimuli.
The aims of this research group are to support and combine best available research expertise from basic science, translational studies and clinical trials to further improve current nutrition practice in ICU patients and to define priorities for further research.
SodiUm SeleniTe Administration IN Cardiac Surgery (SUSTAIN CSX®-trial). A multicentre, randomised controlled trial of high dose sodium-selenite administration in high risk cardiac surgical patients
SustainCSX is an international multicenter study and is currently recruiting. There are 12 German sites and 12 Canadian sites working on this study. Patients scheduled for elective cardiac surgery with combined procedures or with an EuroScore ≥ 5 will be included. Patients receive in total 4000µg of the investigational product intravenously at the day of surgery and 1000µg postoperatively.
The International Nutrition Survey 2018 is based on the previous conducted international surveys by Daren Heyland. By repeating the International Nutrition Survey in 2018, we aim to describe current nutrition practices in cardiac surgery patients and to monitor changes over time worldwide. This survey will show us whether ICUs are able to adhere to the Clinical Practice Guidelines and where we need to start to improve adherence.
A RandomizEd trial of ENtERal Glutamine to minimIZE thermal injury
The Re-Energize Study is a trial lead by Dr. Daren Heyland and his team at the Clinical Evaluation Research Unit (CERU).
The objective of the study is to evaluate effect of glutamine on 6 months mortality in severe burn patients.
This is a large, multicenter, double-blind, pragmatic, randomized controlled trial of 2700 patients with severe burns randomly allocated to receive enteral glutamine or placebo.
“Intravenous Fish Oil based Lipid Emulsion as Pharmaconutrient Strategy in High-Risk Cardiac Surgery Patients: a Phase II Dosing Study”
In this pilot dose-finding study we aim to determine the safety and efficacy / optimal tolerable dose of FO administered intravenously as Omegaven® in high-risk cardiac surgery patients, recruitment of trial patients, adherence to protocol and contamination with other FO products.
Approved by REB and Competent Authority
“A Randomized Trial of post-operative SUPplemental Parenteral nutritiOn and exeRcise in high-risk patienTs undergoing undergoing complex cardiac surgery”
The SupportCSX trial is a multicenter, open labelled, 2 group randomized pilot study. The objective is to safety and feasibility of the treatment. Patients in the intervention group will receive enteral nutrition as per local standards and will be topped up with parenteral nutrition in order to reach 100% nutrition adequacy. Additionally, patients in the intervention group will receive in-bed-cycling. The control group will be treated according to the local standards.
“Clinical relevance of the antimicrobial resistance testing in the treatment of chronic wounds with antiseptics”
AntiSeptic This is a monocentric, prospective, controlled, open, randomized, 2-arm parallel, interventional pilot study. The aim of this clinical trial is to find the most effective local antiseptic therapy for patients suffering from wound infections by resistance testing. For this purpose, only already approved antiseptics are tested and applied. In the control group the wounds are continuously disinfected and dressing within the standard therapy of the most frequently used antisepcti (Lavasept® (polyhexanide)). In the experimental group, the antiseptic to be used is adapted according to the results of the antimicrobial tests.
“The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial”
The EFFORTcombo-Trial is a multicenter, randomized, clinical trial of 142 nutritionally high-risk critically ill patients. This nested EN/PN protocol will be an industry supported sub-study where 142 patients in the EFFORT trial randomized to high dose protein will receive enteral/ parenteral nutrition (EN/PN). For the EN/PN sub study, we aim to enlist the support of 6-8 sites in Germany and Switzerland, which have experience in nutrition studies and assessment of functional outcomes.