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A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00865202
First Posted: March 19, 2009
Last Update Posted: June 1, 2017
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.
Information provided by (Responsible Party):
University of Colorado, Denver
Results First Submitted: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Post-operative Delirium
Interventions: Drug: L-tryptophan supplementation
Drug: placebo

  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
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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
Study Drug L-tryptophan 1 gm enterally TID starting the evening of the operation
Placebo Similar appearing placebo

Participant Flow:   Overall Study
    Study Drug   Placebo
STARTED   152   149 
COMPLETED   152   149 
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.
301 total study participants

Reporting Groups
  Description
L-tryptophan L-tryptophan 1 gm enterally TID starting the evening of the operation
Placebo similar appearing placebo
Total Total of all reporting groups

Baseline Measures
   L-tryptophan   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   149   301 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Overall Study   69  (7)   69  (8)   69  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4   2.6%      2   1.3%      6   2.0% 
Male      148  97.4%      147  98.7%      295  98.0% 
Region of Enrollment 
[Units: Participants]
     
United States   152   149   301 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Duration of Post-operative Delirium   [ Time Frame: post-operatively daily in ICU until discharged from ICU ]

2.  Secondary:   Incidence of Post-operative Delirium   [ Time Frame: post-operatively daily in ICU until discharged from ICU ]

3.  Secondary:   Level of Post-operative Serum Tryptophan   [ Time Frame: post-operative day number two blood draw ]

4.  Secondary:   Level of Post-operative Melatonin   [ Time Frame: Blood draw on post-operative day number two ]

5.  Secondary:   Length of Post-operative ICU and Hospital Stay   [ Time Frame: length of post-op hospital stay ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Thomas Robinson MD
Organization: University of Colorado
phone: 303-724-2728
e-mail: thomas.robinson@ucdenver.edu


Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00865202     History of Changes
Other Study ID Numbers: 08-0543
First Submitted: March 17, 2009
First Posted: March 19, 2009
Results First Submitted: May 27, 2014
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017