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

Stopped early · Phase 3

Conditions studied: Critical Illness, Acute Respiratory Failure

In brief

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.

Key facts

Study ID: NCT01206166
Run by: Clinical Evaluation Research Unit at Kingston General Hospital
People needed: 125
Starts: 2011-06-01
Expected to finish: 2015-07-01
Last updated by the study team: 2021-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Critically ill adult patient (≥ 18 years) admitted to ICU
Has acute respiratory failure (ARF) i.e. expected to remain mechanically ventilated for more than 48 hours
Expected ICU dependency of 5 or more days
On or expected to initiate enteral nutrition within 7 days of ICU admission
BMI <25 or ≥ 35 based on pre-ICU actual or estimated dry weight

You may not qualify if…

>72 hours from admission to ICU to time of consent
Not expected to survive an additional 48 hrs from screening evaluation
A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)
Patients already receiving PN at screening
Absence of All gastrointestinal risk factors, defined as:
High Apache II Score (>20)
On more than 1 vasopressor or increasing doses or vasopressors
Receiving continuous infusion of narcotics
High nasogastric/orogastric output (>500 mL over 24 hours)
Recent surgery involving esophagus, stomach, or small bowel OR peritoneal contamination with bowel contents
Pancreatitis
Multiple gastrointestinal investigations
Recent history of diarrhea/C. Difficile
Surgical patients with future surgeries planned
Ruptured or dissected abdominal aortic aneurysm
Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
Pregnant or lactating patients
Patients with clinical fulminant hepatic failure
Patients with Cirrhosis Child's Class C Liver Disease (except those on a transplant list or transplantable)
Dedicated port of central line not available
Known allergy to study nutrients (soy, eggs or olive products)
Enrolment in another industry sponsored ICU intervention study

Where it is running

University of Colorado DHSC — Boulder, Colorado, United States
Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
Mercy Hospital St. Louis — St Louis, Missouri, United States
Cleveland Clinic Lerner College of Medicine — Cleveland, Ohio, United States
The Ohio State Univsersity Medical Center — Columbus, Ohio, United States
Oregon Health & Science University — Portland, Oregon, United States
University of Texas Health Science Center — Houston, Texas, United States
Erasme University Hospital — Brussels, Belgium
Royal Alexandra Hospital — Edmonton, Alberta, Canada
University of Alberta — Edmonton, Alberta, Canada
Grey Nuns Hospital — Edmonton, Alberta, Canada
Nouvel Hôpital Civil — Strasbourg, France

Full record on ClinicalTrials.gov

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