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NCT01206166 · ClinicalTrials.gov registry record · Phase 3
Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
A Phase 3 study, sponsored by Clinical Evaluation Research Unit at Kingston General Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
NCT01206166: Clinical Trial Phase 3 study, sponsored by Clinical Evaluation Research Unit at Kingston General Hospital.
NCT01206166 is a Phase 3 study that was terminated before completion, run by Clinical Evaluation Research Unit at Kingston General Hospital. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01206166, a Phase 3 study, was terminated before completion, sponsored by Clinical Evaluation Research Unit at Kingston General Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
Study 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.
Primary Outcome
Amount of calories \& protein received as a percentage of prescribed.
Interventions
- DRUG Olimel (5.7%E / N9E)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
Why NCT01206166 stopped before completion
NCT01206166 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Olimel (5.7%E / N9E) is the first listed.
NCT01206166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01206166 about?
NCT01206166 is a clinical study titled "Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)". 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 c...
What is the current status of trial NCT01206166?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2011-06. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01206166?
The interventions under investigation include: Olimel (5.7%E / N9E) (DRUG).
Who is sponsoring clinical trial NCT01206166?
This trial is sponsored by Clinical Evaluation Research Unit at Kingston General Hospital, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01206166's enrollment target sits among peer trials
125 1605th of 2000 higher than 391 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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