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Efficacy and Mechanisms of GLN Dipeptide in the SICU (GLND)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248638
First Posted: November 4, 2005
Last Update Posted: August 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, Emory University
Results First Submitted: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Critical Illness
Interventions: Drug: Glutamine dipeptide with 15% Clinisol
Drug: 15% Clinisol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Glutamine Dipeptide Glutamine dipeptide supplemented nutrition to be given to participants.
Standard Participants given standard nutrition without glutamine dipeptide

Participant Flow:   Overall Study
    Glutamine Dipeptide   Standard
STARTED   75   75 
COMPLETED   75   75 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adults following CABG, cardiac valve, vascular (non-neurosurgical), or small bowel and/or colonic surgery who are deemed likely to require PN for ≥ 7 subsequent days by the attending physicians and investigators are eligible. Potentially eligible subjects admitted to the SICU and deemed to require PN.

Reporting Groups
  Description
Glutamine Dipeptide Glutamine dipeptide supplemented nutrition to be given to participants.
Standard Participants given standard nutrition without glutamine dipeptide
Total Total of all reporting groups

Baseline Measures
   Glutamine Dipeptide   Standard   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   75   150 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   43   50   93 
>=65 years   32   25   57 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (13.6)   60.4  (13.0)   60.3  (13.2) 
Gender 
[Units: Participants]
     
Female   40   30   70 
Male   35   45   80 
Region of Enrollment 
[Units: Participants]
     
United States   75   75   150 


  Outcome Measures
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1.  Primary:   Hospital Mortality   [ Time Frame: Mortality during the current hospitalization up to 6 months ]

2.  Primary:   Percent of Patients Who do Not Develop Hospital Infections After Entry   [ Time Frame: While the patient is admitted during the current hospitalization up to 6 months ]

3.  Secondary:   Gluthatione Levels   [ Time Frame: 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Heat Shock Proteins Levels   [ Time Frame: 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas R. Ziegler M.D.
Organization: Emory University
phone: 4047277354
e-mail: Tzieg01@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas R. Ziegler, MD, Emory University
ClinicalTrials.gov Identifier: NCT00248638     History of Changes
Other Study ID Numbers: IRB00024944
U01DK069322 ( U.S. NIH Grant/Contract )
DK69322 ( Other Identifier: Other )
First Submitted: November 3, 2005
First Posted: November 4, 2005
Results First Submitted: December 19, 2013
Results First Posted: February 13, 2014
Last Update Posted: August 21, 2015