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NCT00248638 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Mechanisms of GLN Dipeptide in the SICU
A Phase 3 study of Critical Illness, sponsored by Emory University.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 5
- Study locations
NCT00248638: Completed Phase 3 study of Critical Illness, sponsored by Emory University.
NCT00248638 is a Phase 3 study of Critical Illness that has completed, run by Emory University. The registered enrollment target is 150 participants, below the 3,137-participant average among 91 other Critical Illness trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00248638, a Phase 3 study of Critical Illness, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 5
- Study locations
Study Summary
Relative glutamine (GLN) deficiency may contribute to morbidity and mortality in surgical intensive care unit (SICU) patients. During critical illness, GLN utilization by the immune system, gut mucosa and other tissues exceeds endogenous production and plasma GLN concentrations decrease, which may contribute to cellular dysfunction and increase nosocomial infection risk and mortality. Conventional GLN-free parenteral nutrition (PN) has a limited impact on SICU outcomes and does not repair the GLN deficit. Recent pilot data show that GLN dipeptide-supplemented PN decreases nosocomial infections and improves clinical outcomes in SICU patients. The process of benefit is poorly understood, but animal and human data suggest that GLN treatment correlates with a) up-regulation of cytoprotective molecules in blood and tissues \[e.g, GSH, specific heat shock proteins (HSPs) and GLN\]; and b) improved epithelial barrier defenses and immune cell number and function. Properties of L-GLN limit provision in solution, but the GLN dipeptide alanyl-GLN (AG) confers stability and solubility in PN (AG-PN). Investigators propose a multicenter, double-blind, randomized, controlled phase III trial based on our pilot data to test the hypothesis that AG-PN improves clinical outcomes in SICU patients requiring PN after cardiac, vascular or colonic operations. Subjects will receive either standard GLN-free PN or isocaloric, isonitrogenous, AG-PN until enteral feeds are established. Specific Aim 1 is to determine whether AG-PN decreases hospital mortality, nosocomial infection and other important indices of morbidity. Specific Aim 2 is to obtain novel, mechanistically relevant observational data in the Aim 1 subjects on whether AG-PN a) increases serial blood levels of GSH, HSP-70 and -27, and GLN; b) decreases the presence in serum of the bacterial products flagellin and LPS and the adaptive immune response to these mediators; and c) improves key indices of innate/adaptive immunity. This stu
Primary Outcome
Number of participants who died during hospitalization.
Conditions Studied
Interventions
- DRUG Glutamine dipeptide with 15% Clinisol
- DRUG 15% Clinisol
Study Locations (5)
Colorado
- University of Colorado Health Sciences Center - Denver
Georgia
- Emory University - Atlanta
Rhode Island
- The Miriam Hospital/Brown University - Providence
Tennessee
- Vanderbilt University - Nashville
Wisconsin
- University Of Wisconsin Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT00248638 record still lists
NCT00248638 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 3,137-participant average among 91 other Critical Illness trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Critical Illness appearing as the primary indexed condition, and to 2 interventions - of which Glutamine dipeptide with 15% Clinisol is the first listed.
NCT00248638 lists 5 locations in 5 states (Colorado, Georgia, Rhode Island).
Frequently Asked Questions
What is clinical trial NCT00248638 about?
NCT00248638 is a clinical study titled "Efficacy and Mechanisms of GLN Dipeptide in the SICU". Relative glutamine (GLN) deficiency may contribute to morbidity and mortality in surgical intensive care unit (SICU) patients. During critical illness, GLN utilization by the immune system, gut mucosa and other tissues exceeds endogenous production and plasma GLN concentrations decrease, which may c...
What is the current status of trial NCT00248638?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2006-09. Estimated completion is 2012-12.
What conditions does trial NCT00248638 study?
This clinical trial studies the following conditions: Critical Illness.
What interventions are being tested in trial NCT00248638?
The interventions under investigation include: Glutamine dipeptide with 15% Clinisol (DRUG), 15% Clinisol (DRUG).
Who is sponsoring clinical trial NCT00248638?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00248638 being conducted?
This trial has 5 study locations across Colorado, Georgia, Rhode Island, Tennessee, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00248638's enrollment target sits among peer trials
150 56th of 91 higher than 35 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness 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.
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