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

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ClinicalTrials.gov Identifier: NCT00248638
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : February 13, 2014
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, Emory University

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      43  57.3%      50  66.7%      93  62.0% 
>=65 years      32  42.7%      25  33.3%      57  38.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (13.6)   60.4  (13.0)   60.3  (13.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      40  53.3%      30  40.0%      70  46.7% 
Male      35  46.7%      45  60.0%      80  53.3% 
Region of Enrollment 
[Units: Participants]
     
United States   75   75   150 


  Outcome Measures

1.  Primary:   Hospital Mortality Rate   [ Time Frame: Current Hospitalization (Up to 6 Months) ]

2.  Primary:   Percentage of Patients Who do Not Develop Hospital Infections   [ Time Frame: Current Hospitalization (Up to 6 Months) ]

3.  Secondary:   Mean Glutathione Level   [ Time Frame: Baseline, Day 3, Day 7, Day 14, Day 21, Day 28 ]

4.  Secondary:   Mean Heat Shock Proteins Level, HSP70   [ Time Frame: Baseline, Day 3, Day 7, Day 14, Day 21, Day 28 ]

5.  Secondary:   Mean Heat Shock Proteins Level, HSP27   [ Time Frame: Baseline, Day 3, Day 7, Day 14, Day 21, Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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: January 23, 2018