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

Completed · Phase 3 · Has a placebo group

Conditions studied: Post-operative Delirium

In brief

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.

Key facts

Study ID

NCT00865202

Run by

University of Colorado, Denver

People needed

301

Starts

2008-12-01

Expected to finish

2012-12-01

Last updated by the study team

2017-06-01

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• Denver Veterans Affairs Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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