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

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ClinicalTrials.gov Identifier: NCT00865202
Recruitment Status : Completed
First Posted : March 19, 2009
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
Post-operative delirium is a common and deleterious complication in elderly patients. The investigators have previously found lower levels of serum tryptophan in post-operative elderly patients who developed delirium in comparison to post-operative elderly patients who did not develop delirium. The investigators hypothesize that post-operative supplementation of L-tryptophan will reduce the duration and incidence of post-operative delirium. This study is a double-blinded placebo controlled trial of L-tryptophan supplementation in post-operative ICU patients 60 years and older. The primary outcome measure is the comparison of duration of post-operative delirium in subjects who receive L-tryptophan supplementation versus a similar appearing control.

Condition or disease Intervention/treatment Phase
Post-operative Delirium Drug: L-tryptophan supplementation Drug: placebo Phase 3

Detailed Description:
The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
Study Start Date : December 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Tryptophan

Arms and Interventions
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Arm Intervention/treatment
Experimental: L-Tryptophan
L-tryptophan supplementation (1 gram enterally three times per day) starting post-operatively and continuing for a maximum of 9 doses or the time of discharge from ICU (whichever occurs first)
 Drug: L-tryptophan supplementation
L-tryptophan 1 gram enterally TID for a maximum of nine doses or to be discontinued at the time of discharge from the ICU (whichever occurs first)
Other Name: L-tryptophan 1 gm PO TID starting the evening of surgery
Placebo Comparator: Placebo
Similar appearing placebo administered post-operatively (1 enterally three times per day) for a total of nine doses or discharge from ICU (whichever occurs first)
 Drug: L-tryptophan supplementation
L-tryptophan 1 gram enterally TID for a maximum of nine doses or to be discontinued at the time of discharge from the ICU (whichever occurs first)
Other Name: L-tryptophan 1 gm PO TID starting the evening of surgery

Drug: placebo
Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)
Other Name: Similar appearing placebo


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

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

    The incidence and/or duration of excitatory (hyperactive and mixed) post-operative delirium, diagnosed by the Confusion Assessment Method-ICU (CAM-ICU) with the Richmond Agitation Sedation Score (RASS), will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission.

    The incidence and/or duration of all types of post-operative delirium, diagnosed by the CAM-ICU with the RASS, will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission.


  2. Level of Post-operative Serum Tryptophan [ Time Frame: post-operative day number two blood draw ]
  3. Level of Post-operative Melatonin [ Time Frame: Blood draw on post-operative day number two ]
  4. Length of Post-operative ICU and Hospital Stay [ Time Frame: length of post-op hospital stay ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.

Exclusion Criteria:

  • Medications that, when combined with tryptophan, increase the risk of serotonin syndrome. The classes of medications include:

    • monoamine oxidase inhibitors
    • selective serotonin reuptake inhibitors
    • serotonin-norepinephrine reuptake inhibitors
    • triptans
    • opioids
    • central nervous system stimulants
    • bupropion
    • St. John's Wort
  • Patients who undergo an operation on their brain.
  • Factors which prevent delirium assessment with the CAM-ICU: vision impairment or non-fluent English speakers.

  • A lowered seizure threshold including:

    • history of seizure disorder
    • alcohol abuse defined by a high AUDIT score (>8 females and >13 males)
    • benzodiazepine or barbiturate abuse within three months of the study
    • OR a positive urine toxicology screen for alcohol, benzodiazepines or barbiturates.
  • Significant liver disease (Child's class B or greater) or significant renal disease (Creatinine ≥2.0).
  • History of Huntington's or Addison's disease. (As requested by the FDA)
  • History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia). (As requested by the FDA)
  • Women who are not post-menopausal. (As requested by the FDA)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865202


Locations
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United States, Colorado
Denver Veterans Affairs Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Thomas Robinson, MD University of Colorado, Denver
More Information
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Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00865202    
Other Study ID Numbers: 08-0543
First Posted: March 19, 2009    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Keywords provided by University of Colorado, Denver:
delirium
surgery
operation
geriatric
complication
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs