drugset / Trial / NCT00865202

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

NCT00865202

Phase 3 Completed 301 enrolled University of Colorado, Denver
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2008-12
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject amino acids Unknown 1 g Other

Indications