Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
Status:
Terminated
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
The specific aim of the proposed study is to conduct a pilot study involving 160
critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of
America, Belgium and France in order to:
Specific Aims
- Confirm that we can achieve a clinically significant difference in calorie and protein
intake between the two intervention groups.
- Estimate recruitment rate i.e. number of eligible and enrolled patients per month per
site.
- Evaluate the safety, tolerance, and logistics around providing supplemental PN in the
study population in the context of a multicenter trial, e.g.
- To ensure adequate glycemic control in both groups.
- To ensure that the other metabolic consequences of the feeding strategies are
minimized.
- To establish adequate compliance with study protocols and completion of case report
forms
A secondary aim of this pilot study will be:
• To explore the effect of differential effects of calorie and protein delivery on muscle and
mass function.
Phase:
Phase 3
Details
Lead Sponsor:
Clinical Evaluation Research Unit at Kingston General Hospital