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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01206166

Public ClinicalTrials.gov record NCT01206166. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 9:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01206166
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Enrollment
125 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2011 (Type not available)
Primary completion
Mar 2015 (Actual)
Completion
Jul 2015 (Actual)
Last update posted
Mar 16, 2021

2011 – 2015

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
University of Colorado DHSC Boulder Colorado 80045 —
Washington University School of Medicine in St. Louis St Louis Missouri 63110-1093 —
Mercy Hospital St. Louis St Louis Missouri 63141 —
Cleveland Clinic Lerner College of Medicine Cleveland Ohio 44195 —
The Ohio State Univsersity Medical Center Columbus Ohio 43221 —
Oregon Health & Science University Portland Oregon 97239-3098 —
University of Texas Health Science Center Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01206166, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 16, 2021 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01206166 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →