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Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)

NCT01206166 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2021-03-16

Study results available
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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.

Conditions

  • Critical Illness
  • Acute Respiratory Failure

Interventions

DRUG

Olimel (5.7%E / N9E)

OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Clinical Evaluation Research Unit at Kingston General Hospital

    lead OTHER

Principal Investigators

  • Daren K. Heyland, MD · Clinical Evaluation Research Unit, Kingston General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-03-31
Completion
2015-07-31

Countries

  • United States
  • Belgium
  • Canada
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206166 on ClinicalTrials.gov