NCT00865202

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.

Conditions

• Post-operative Delirium

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-03-19
• Last updated: 2017-06-01
• Results posted: 2017-06-01

Locations

1 site across 1 country: United States