Status:
COMPLETED
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
Lead Sponsor:
University of Colorado, Denver
Conditions:
Post-operative Delirium
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 de...
Detailed Description
The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.
Eligibility Criteria
Inclusion
- Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00865202
Start Date
December 1 2008
End Date
December 1 2012
Last Update
June 1 2017
Active Locations (1)
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1
Denver Veterans Affairs Medical Center
Denver, Colorado, United States, 80220