Trial Outcomes & Findings for A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium (NCT NCT00865202)

NCT ID: NCT00865202

Last Updated: 2017-06-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 301 participants
• Primary outcome timeframe: post-operatively daily in ICU until discharged from ICU
• Results posted on: 2017-06-01

Participant Flow

Participant milestones

Measure	Study Drug L-tryptophan 1 gm enterally TID starting the evening of the operation	Placebo Similar appearing placebo
Overall Study STARTED	152	149
Overall Study COMPLETED	152	149
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	L-tryptophan n=152 Participants L-tryptophan 1 gm enterally TID starting the evening of the operation	Placebo n=149 Participants similar appearing placebo	Total n=301 Participants Total of all reporting groups
Age, Continuous Overall Study	69 years STANDARD_DEVIATION 7 • n=5 Participants	69 years STANDARD_DEVIATION 8 • n=7 Participants	69 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	147 Participants n=7 Participants	295 Participants n=5 Participants
Region of Enrollment United States	152 participants n=5 Participants	149 participants n=7 Participants	301 participants n=5 Participants

PRIMARY outcome

Timeframe: post-operatively daily in ICU until discharged from ICU

Outcome measures

Measure	Study Drug n=152 Participants L-tryptophan 1 gm PO TID starting the evening of surgery	Placebo n=149 Participants similar appearing placebo
Duration of Post-operative Delirium	3.3 days Standard Deviation 1.7	3.1 days Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Study Drug n=152 Participants L-tryptophan 1 gm PO TID starting the evening of surgery	Placebo n=149 Participants similar appearing placebo
Incidence of Post-operative Delirium	17 percentage of patient escitatorydelirium	9 percentage of patient escitatorydelirium

SECONDARY outcome

Timeframe: post-operative day number two blood draw

Outcome measures

Measure	Study Drug n=152 Participants L-tryptophan 1 gm PO TID starting the evening of surgery	Placebo n=149 Participants similar appearing placebo
Level of Post-operative Serum Tryptophan	65 umol/L Standard Deviation 26	41 umol/L Standard Deviation 15

SECONDARY outcome

Timeframe: Blood draw on post-operative day number two

Outcome measures

Measure	Study Drug n=152 Participants L-tryptophan 1 gm PO TID starting the evening of surgery	Placebo n=149 Participants similar appearing placebo
Level of Post-operative Melatonin	20 pg/mL Standard Deviation 31	19 pg/mL Standard Deviation 41

SECONDARY outcome

Timeframe: length of post-op hospital stay

Outcome measures

Measure	Study Drug n=152 Participants L-tryptophan 1 gm PO TID starting the evening of surgery	Placebo n=149 Participants similar appearing placebo
Length of Post-operative ICU and Hospital Stay	10 days Standard Deviation 8.4	9.7 days Standard Deviation 8.7

Adverse Events

Study Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Robinson MD

University of Colorado

Phone: 303-724-2728

Email: thomas.robinson@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee The manuscript has been accepted by the Journal of the American Geriatrics Society for publication.
• Publication restrictions are in place

Restriction type: OTHER