Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-01-29 @ 10:04 AM
Study NCT ID:
NCT00865202
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.robinson@ucdenver.edu', 'phone': '303-724-2728', 'title': 'Thomas Robinson MD', 'organization': 'University of Colorado'}, 'certainAgreement': {'otherDetails': 'The manuscript has been accepted by the Journal of the American Geriatrics Society for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Postoperative Nausea', 'description': 'Postoperative Nausea', 'eventGroups': [{'id': 'EG000', 'title': 'Study Drug', 'description': 'L-tryptophan 1 gm enterally TID starting the evening of the operation', 'otherNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Similar appearing placebo', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Post-operative Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'L-tryptophan 1 gm PO TID starting the evening of surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'similar appearing placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-operatively daily in ICU until discharged from ICU', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Post-operative Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'L-tryptophan 1 gm PO TID starting the evening of surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'similar appearing placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'post-operatively daily in ICU until discharged from ICU', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'percentage of patient escitatorydelirium', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Level of Post-operative Serum Tryptophan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'L-tryptophan 1 gm PO TID starting the evening of surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'similar appearing placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '26', 'groupId': 'OG000'}, {'value': '41', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-operative day number two blood draw', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Level of Post-operative Melatonin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'L-tryptophan 1 gm PO TID starting the evening of surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Similar appearing placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '31', 'groupId': 'OG000'}, {'value': '19', 'spread': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood draw on post-operative day number two', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Post-operative ICU and Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'L-tryptophan 1 gm PO TID starting the evening of surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Similar appearing placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'length of post-op hospital stay', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Drug', 'description': 'L-tryptophan 1 gm enterally TID starting the evening of the operation'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Similar appearing placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'L-tryptophan', 'description': 'L-tryptophan 1 gm enterally TID starting the evening of the operation'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'similar appearing placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Overall Study', 'categories': [{'measurements': [{'value': '69', 'spread': '7', 'groupId': 'BG000'}, {'value': '69', 'spread': '8', 'groupId': 'BG001'}, {'value': '69', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '301 total study participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2009-03-17', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Post-operative Delirium', 'timeFrame': 'post-operatively daily in ICU until discharged from ICU'}], 'secondaryOutcomes': [{'measure': 'Incidence of Post-operative Delirium', 'timeFrame': 'post-operatively daily in ICU until discharged from ICU', 'description': '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.\n\nThe 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.'}, {'measure': 'Level of Post-operative Serum Tryptophan', 'timeFrame': 'post-operative day number two blood draw'}, {'measure': 'Level of Post-operative Melatonin', 'timeFrame': 'Blood draw on post-operative day number two'}, {'measure': 'Length of Post-operative ICU and Hospital Stay', 'timeFrame': 'length of post-op hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['delirium', 'surgery', 'operation', 'geriatric', 'complication'], 'conditions': ['Post-operative Delirium']}, 'referencesModule': {'references': [{'pmid': '18789427', 'type': 'BACKGROUND', 'citation': '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': '19106695', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.\n\nExclusion Criteria:\n\n* Medications that, when combined with tryptophan, increase the risk of serotonin syndrome. The classes of medications include:\n\n * monoamine oxidase inhibitors\n * selective serotonin reuptake inhibitors\n * serotonin-norepinephrine reuptake inhibitors\n * triptans\n * opioids\n * central nervous system stimulants\n * bupropion\n * St. John's Wort\n* Patients who undergo an operation on their brain.\n* Factors which prevent delirium assessment with the CAM-ICU: vision impairment or non-fluent English speakers.\n* A lowered seizure threshold including:\n\n * history of seizure disorder\n * alcohol abuse defined by a high AUDIT score (\\>8 females and \\>13 males)\n * benzodiazepine or barbiturate abuse within three months of the study\n * OR a positive urine toxicology screen for alcohol, benzodiazepines or barbiturates.\n* Significant liver disease (Child's class B or greater) or significant renal disease (Creatinine ≥2.0).\n* History of Huntington's or Addison's disease. (As requested by the FDA)\n* 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)\n* Women who are not post-menopausal. (As requested by the FDA)"}, 'identificationModule': {'nctId': 'NCT00865202', 'briefTitle': 'A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium', 'orgStudyIdInfo': {'id': '08-0543'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-Tryptophan', 'description': '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)', 'interventionNames': ['Drug: L-tryptophan supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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)', 'interventionNames': ['Drug: L-tryptophan supplementation', 'Drug: placebo']}], 'interventions': [{'name': 'L-tryptophan supplementation', 'type': 'DRUG', 'otherNames': ['L-tryptophan 1 gm PO TID starting the evening of surgery'], 'description': '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)', 'armGroupLabels': ['L-Tryptophan', 'Placebo']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Similar appearing placebo'], 'description': 'Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Thomas Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}