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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Tryptophan

Criteria

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)