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Trial record 1 of 1 for:    A Placebo Controlled Trial of L-Tryptophan in Post-Operative Delirium
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A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00865202
First received: March 17, 2009
Last updated: March 27, 2013
Last verified: March 2013

March 17, 2009
March 27, 2013
December 2008
December 2012   (final data collection date for primary outcome measure)
Duration of post-operative delirium [ Time Frame: post-operatively in ICU ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865202 on ClinicalTrials.gov Archive Site
  • Incidence of post-operative delirium [ Time Frame: post-operatively in ICU ] [ Designated as safety issue: No ]

    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.

  • Level of post-operative serum tryptophan [ Time Frame: post-operative day number two blood draw ] [ Designated as safety issue: No ]
  • level of post-operative serotonin and melatonin [ Time Frame: Blood draw on post-operative day number two ] [ Designated as safety issue: No ]
  • Length of post-operative ICU and hospital stay [ Time Frame: length of post-op ICU and hospital stay ] [ Designated as safety issue: No ]
  • Incidence of post-operative delirium [ Time Frame: post-operatively in ICU ] [ Designated as safety issue: No ]
  • Level of post-operative serum tryptophan [ Time Frame: post-operative day number two blood draw ] [ Designated as safety issue: No ]
  • level of post-operative serotonin and melatonin [ Time Frame: Blood draw on post-operative day number two ] [ Designated as safety issue: No ]
  • Length of post-operative ICU and hospital stay [ Time Frame: length of post-op ICU and hospital stay ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Post-operative Delirium
  • 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)
  • Drug: placebo
    Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)
  • Experimental: L-Tryptophan
    L-tryptophan supplementation (1 gram enterally TID) starting post-operatively and continuing for a maximum of 9 doses or the time of discharge from ICU (whichever occurs first)
    Intervention: Drug: L-tryptophan supplementation
  • Placebo Comparator: Placebo
    Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)
    Interventions:
    • Drug: L-tryptophan supplementation
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00865202
08-0543
Yes
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Thomas Robinson, MD University of Colorado, Denver
University of Colorado, Denver
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP