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Completed

NCT Number: NCT00865202

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

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.

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Key information

Conditions

Post-operative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Denver Veterans Affairs Medical Center

Denver, Colorado, 80220, United States

About this study

The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Other names: L-tryptophan 1 gm PO TID starting the evening of surgery

Placebo

Drug

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

Other names: Similar appearing placebo

Primary outcomes

  1. Duration of Post-operative Delirium

    Time frame: post-operatively daily in ICU until discharged from ICU

Secondary outcomes

  1. 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.

  2. Level of Post-operative Serum Tryptophan

    Time frame: post-operative day number two blood draw

  3. Level of Post-operative Melatonin

    Time frame: Blood draw on post-operative day number two

  4. Length of Post-operative ICU and Hospital Stay

    Time frame: length of post-op hospital stay

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 19, 2009
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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