Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
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.
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
Conditions
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
- May 31, 2011
- Primary completion
- Feb 28, 2015
- Completion
- Jun 30, 2015
- Last update posted
- Mar 15, 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 15, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01206166 live on ClinicalTrials.gov.