Trial · NCT00248638

Efficacy and Mechanisms of GLN Dipeptide in the SICU

NCT00248638, Phase 3, Completed, Emory University; results first posted 2014-02-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Mechanisms of GLN Dipeptide in the SICU. Trials, record NCT00248638. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00248638

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Mechanisms of GLN Dipeptide in the SICU
NCT number: NCT00248638
Status: Completed
Phases: Phase 3
Enrollment: 150 participants, actual
Lead sponsor: Emory University
Conditions: Critical Illness
Interventions: Glutamine dipeptide with 15% Clinisol, 15% Clinisol
First posted: 2005-11-04
Last updated: 2018-01-23
Results first posted: 2014-02-13

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hospital Mortality Rate	Current Hospitalization (Up to 6 Months)	Number of participants who died during hospitalization.
Primary	Percentage of Patients Who do Not Develop Hospital Infections	Current Hospitalization (Up to 6 Months)	Subjects remaining infection-free during the hospitalization.
Secondary	Mean Glutathione Level	Baseline, Day 3, Day 7, Day 14, Day 21, Day 28	Glutathione (GSH) levels will be measured in µM (micro moles) from baseline to day 28. Higher levels indicate a higher GSH presence.
Secondary	Mean Heat Shock Proteins Level, HSP70	Baseline, Day 3, Day 7, Day 14, Day 21, Day 28	Levels of the heat shock protein,HSP70, will be measured in ng/mL from baseline to day 28. Higher levels indicate a higher protein presence.
Secondary	Mean Heat Shock Proteins Level, HSP27	Baseline, Day 3, Day 7, Day 14, Day 21, Day 28	Levels of the heat shock protein, HSP27, will be measured in pg/mL from baseline to day 28. Higher levels indicate a higher protein presence.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hospital Mortality Rate	Current Hospitalization (Up to 6 Months)		participants	NUMBER
PRIMARY	Percentage of Patients Who do Not Develop Hospital Infections	Current Hospitalization (Up to 6 Months)		percentage of participants	NUMBER
SECONDARY	Mean Glutathione Level	Baseline, Day 3, Day 7, Day 14, Day 21, Day 28	The number of participants currently hospitalized are included in each time point analysis.	µM	MEAN
SECONDARY	Mean Heat Shock Proteins Level, HSP70	Baseline, Day 3, Day 7, Day 14, Day 21, Day 28	The number of participants currently hospitalized are included in each time point analysis.	ng/mL	MEAN
SECONDARY	Mean Heat Shock Proteins Level, HSP27	Baseline, Day 3, Day 7, Day 14, Day 21, Day 28	The number of participants currently hospitalized are included in each time point analysis.	pg/mL	MEAN

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Hospital Mortality Rate	Glutamine Dipeptide		11		participants
Hospital Mortality Rate	Standard		13		participants
Percentage of Patients Who do Not Develop Hospital Infections	Glutamine Dipeptide		56		percentage of participants
Percentage of Patients Who do Not Develop Hospital Infections	Standard		69		percentage of participants
Mean Glutathione Level	Glutamine Dipeptide	Baseline	1.850	Standard Deviation .195	µM
Mean Glutathione Level	Standard	Baseline	1.880	Standard Deviation .182	µM
Mean Glutathione Level	Glutamine Dipeptide	Day 3	1.524	Standard Deviation .156	µM
Mean Glutathione Level	Standard	Day 3	1.374	Standard Deviation .162	µM
Mean Glutathione Level	Glutamine Dipeptide	Day 7	5.056	Standard Deviation 3.619	µM
Mean Glutathione Level	Standard	Day 7	1.473	Standard Deviation .202	µM

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Glutamine Dipeptide	75
Overall Study	STARTED	Standard	75
Overall Study	COMPLETED	Glutamine Dipeptide	75
Overall Study	COMPLETED	Standard	75
Overall Study	NOT COMPLETED	Glutamine Dipeptide	0
Overall Study	NOT COMPLETED	Standard	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	respiratory distress	Respiratory, thoracic and mediastinal disorders	Glutamine Dipeptide	13	75	14
other	respiratory distress	Respiratory, thoracic and mediastinal disorders	Standard	11	75	14
other	tracheostomy	Respiratory, thoracic and mediastinal disorders	Glutamine Dipeptide	22	75	22
other	tracheostomy	Respiratory, thoracic and mediastinal disorders	Standard	12	75	12
other	significant bleeding	General disorders	Glutamine Dipeptide	9	75	11
other	significant bleeding	General disorders	Standard	6	75	7
other	ICU readmission	General disorders	Glutamine Dipeptide	14	75	16
other	ICU readmission	General disorders	Standard	10	75	13
serious	death	General disorders	Glutamine Dipeptide	15	75	15
serious	death	General disorders	Standard	19	75	19

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glutamine Dipeptide	11	75
Total, all-cause mortality	Standard	13	75
Total, other adverse events	Glutamine Dipeptide	22	75
Total, other adverse events	Standard	12	75
Total, serious adverse events	Glutamine Dipeptide	39	75
Total, serious adverse events	Standard	40	75

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26501700	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK069322	Efficacy and Mechanisms of GLN Dipeptide in the SICU	ZIEGLER, THOMAS R	EMORY UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2005 to 2012

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Glutamine Dipeptide vs Standard: Hospital Mortality Rate	Trial comparisons
Glutamine Dipeptide vs Standard: deaths from any cause	Trial comparisons
Glutamine Dipeptide vs Standard: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00248638

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