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A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
This study has been completed.
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00865202
First received: March 17, 2009
Last updated: May 26, 2017
Last verified: May 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Post-operative Delirium | Drug: L-tryptophan supplementation Drug: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Duration of Post-operative Delirium [ Time Frame: post-operatively daily in ICU until discharged from ICU ]
Secondary Outcome Measures:
- Incidence of Post-operative Delirium [ Time Frame: post-operatively daily in ICU until discharged from ICU ]
The incidence and/or duration of excitatory (hyperactive and mixed) post-operative delirium, diagnosed by the Confusion Assessment Method-ICU (CAM-ICU) with the Richmond Agitation Sedation Score (RASS), will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission.
The incidence and/or duration of all types of post-operative delirium, diagnosed by the CAM-ICU with the RASS, will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission.
- Level of Post-operative Serum Tryptophan [ Time Frame: post-operative day number two blood draw ]
- Level of Post-operative Melatonin [ Time Frame: Blood draw on post-operative day number two ]
- Length of Post-operative ICU and Hospital Stay [ Time Frame: length of post-op hospital stay ]
| Enrollment: | 301 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: L-Tryptophan
L-tryptophan supplementation (1 gram enterally three times per day) starting post-operatively and continuing for a maximum of 9 doses or the time of discharge from ICU (whichever occurs first)
|
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)
Other Name: L-tryptophan 1 gm PO TID starting the evening of surgery
|
|
Placebo Comparator: Placebo
Similar appearing placebo administered post-operatively (1 enterally three times per day) for a total of nine doses or discharge from ICU (whichever occurs first)
|
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)
Other Name: L-tryptophan 1 gm PO TID starting the evening of surgery
Drug: placebo
Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)
Other Name: Similar appearing placebo
|
Detailed Description:
The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.
Eligibility| Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00865202
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865202
Locations
| United States, Colorado | |
| Denver Veterans Affairs Medical Center | |
| Denver, Colorado, United States, 80220 | |
Sponsors and Collaborators
University of Colorado, Denver
Investigators
| Principal Investigator: | Thomas Robinson, MD | University of Colorado, Denver |
More Information
Publications:
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00865202 History of Changes |
| Other Study ID Numbers: |
08-0543 |
| Study First Received: | March 17, 2009 |
| Results First Received: | May 27, 2014 |
| Last Updated: | May 26, 2017 |
Keywords provided by University of Colorado, Denver:
|
delirium surgery operation geriatric complication |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Neurocognitive Disorders Mental Disorders Tryptophan Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on September 21, 2017