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

NCT00865202 | Completed Phase 3 Results DMC

• 1 other identifier: 08-0543
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-operative Delirium

Keywords

delirium; surgery; operation; geriatric; complication

Outcome Measures

Primary Outcomes (1)

• Duration of Post-operative Delirium

  post-operatively daily in ICU until discharged from ICU

Secondary Outcomes (4)

• Incidence of Post-operative Delirium

  post-operatively daily in ICU until discharged from ICU

• Level of Post-operative Serum Tryptophan

  post-operative day number two blood draw

• Level of Post-operative Melatonin

  Blood draw on post-operative day number two

• Length of Post-operative ICU and Hospital Stay

  length of post-op hospital stay

Study Arms (2)

L-Tryptophan

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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; Drug: placebo

Interventions

L-tryptophan supplementation DRUG

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)

Also known as: L-tryptophan 1 gm PO TID starting the evening of surgery

L-Tryptophan; Placebo

placebo DRUG

Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)

Also known as: Similar appearing placebo

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Denver Veterans Affairs Medical Center

Denver, Colorado, 80220, United States

Location

Related Publications (2)

• Robinson TN, Raeburn CD, Angles EM, Moss M. Low tryptophan levels are associated with postoperative delirium in the elderly. Am J Surg. 2008 Nov;196(5):670-4. doi: 10.1016/j.amjsurg.2008.07.007. Epub 2008 Sep 11.

  PMID: 18789427 BACKGROUND

• Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776.

  PMID: 19106695 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Thomas Robinson MD
• Organization: University of Colorado

thomas.robinson@ucdenver.edu

303-724-2728

Study Officials

• Thomas Robinson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Locations

US (1)