Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00248638
The ClinicalTrials.gov registry entry for NCT00248638 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,137-participant average among 91 other Critical Illness trials with a reported enrollment target (95% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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
Similar trials for Critical Illness
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
RECRUITING · Phase 3
-
Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients
ACTIVE NOT RECRUITING · Phase 3
-
Strategy to Avoid Excessive Oxygen in Major Burn Patients
ACTIVE NOT RECRUITING · Phase 3
-
Supplemental Enteral Protein in Critical Illness
COMPLETED · Phase 3
-
Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients
COMPLETED · Phase 3
-
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.