A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | December 2008 |
| Contact: | Thomas Robinson, MD |
| Email: | thomas.robinson@ucdenver.edu |
| Phone: | 303-724-2728 |
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.
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
- opiods
- 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)
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