Post-operative DeliriumPhase 3NCT00865202
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
A Phase 3 study testing L-tryptophan supplementation in people with Post-operative Delirium, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Post-operative Delirium
- What is being tested?
- L-tryptophan supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Veterans Affairs Medical Center
Denver, Colorado, 80220
About this study
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.
Read the detailed description
The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.
- Conditions
- Post-operative Delirium
- Being tested
- L-tryptophan supplementation, placebo
- Keywords
- delirium, surgery, operation, geriatric, complication
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-tryptophan supplementationDrug
Also called L-tryptophan 1 gm PO TID starting the evening of surgery
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)
placeboDrug
Also called Similar appearing placebo
Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: L-tryptophan supplementation; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Post-operative Delirium
Measured: post-operatively daily in ICU until discharged from ICU
Secondary outcomes (4)
Incidence of Post-operative Delirium
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.
Measured: post-operatively daily in ICU until discharged from ICU
Level of Post-operative Serum Tryptophan
Measured: post-operative day number two blood draw
Level of Post-operative Melatonin
Measured: Blood draw on post-operative day number two
Length of Post-operative ICU and Hospital Stay
Measured: length of post-op hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Robinson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865202
- Sponsor's protocol ID
- 08-0543
- Status last verified
- May 2017
- First submitted
- 17 Mar 2009
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 18789427Robinson 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.
PubMed 19106695
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
- ClinicalTrials.gov ID
- NCT00865202
- Acronym / sponsor ID
- 08-0543
- Conditions
- Post-operative Delirium
- Keywords
- delirium, surgery, operation, geriatric, complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-Tryptophan | Experimental | Drug: L-tryptophan supplementationL-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) |
| Placebo | Placebo comparator | Drug: L-tryptophan supplementation, Drug: placeboSimilar appearing placebo administered post-operatively (1 enterally three times per day) for a total of nine doses or discharge from ICU (whichever occurs first) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.
Key exclusion criteria (20 listed)
- Medications that, when combined with tryptophan, increase the risk of serotonin syndrome. The classes of medications include:
- 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:
- Significant liver disease (Child's class B or greater) or significant renal disease (Creatinine ≥2.0).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-tryptophan supplementationAlso: L-tryptophan 1 gm PO TID starting the evening of surgeryL-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) | Drug | L-Tryptophan, Placebo |
| placeboAlso: Similar appearing placeboSimilar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first) | Drug | Placebo |
Primary outcome
Duration of Post-operative Delirium
Time frame: post-operatively daily in ICU until discharged from ICU
4 secondary outcomes
Incidence of Post-operative Delirium
Time frame: post-operatively daily in ICU until discharged from ICU
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18789427Robinson 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.
- Background: PubMed 19106695Robinson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Robinson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-tryptophan supplementation in people with Post-operative Delirium, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Post-operative Delirium (time frame: post-operatively daily in ICU until discharged from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00865202, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.