Phase 3
N=301
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
Post-operative Delirium
Bottom Line
View on ClinicalTrials.gov: NCT00865202 ↗Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Duration of Post-operative Delirium — 3.3; 3.1 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- L-tryptophan supplementation (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Post-operative Delirium |
3.3; 3.1 | — |
| SECONDARY Incidence of Post-operative Delirium |
17; 9 | — |
| SECONDARY Level of Post-operative Serum Tryptophan |
65; 41 | — |
| SECONDARY Level of Post-operative Melatonin |
20; 19 | — |
| SECONDARY Length of Post-operative ICU and Hospital Stay |
10; 9.7 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00865202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.