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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00248638
First received: November 3, 2005
Last updated: December 19, 2013
Last verified: December 2013
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Critical Illness
Intervention: Drug: Glutamine dipeptide

  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  
Number of Participants  
[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:   Blood Cytoprotective Molecules (Glutamine, Heat Shock Protein)   [ Time Frame: Within 28 days of enrollment ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: Thomas R. Ziegler, MD, Emory University
ClinicalTrials.gov Identifier: NCT00248638     History of Changes
Other Study ID Numbers: IRB00024944, U01DK069322, DK69322
Study First Received: November 3, 2005
Results First Received: December 19, 2013
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration