Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
Study NCT ID:
NCT01050712
Status:
TERMINATED
Last Update Posted:
2015-11-17
First Post:
2010-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525108', 'term': 'apoptosis-induced regulator protein'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'According to retired PI, resident graduated and next resident never carried it to fruition.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-15', 'studyFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of post operative ileus (radiologic)', 'timeFrame': '1 week'}, {'measure': 'Incidence of pathological post operative ileus', 'timeFrame': '1 week'}, {'measure': 'Duration of post operative ileus (clinical)', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileus']}, 'descriptionModule': {'briefSummary': 'Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.\n\nA preliminary study will be conducted in six healthy volunteers to monitor for blood levels and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation. Length of normal POI and occurrence of POI complications will be compared between the two groups. Side effects that occur from inhaling CO or oxygen will also be recorded.\n\nWe hypothesize that inhaling CO before and after colon surgery will shorten the length of normal POI and decrease the occurrence of POI complications with minimal side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, age \\> 18 years.\n* Women must be using acceptable contraceptives, post-menopausal or surgically sterile.\n* No prior smoking history.\n* BMI between 16 and 30 inclusive.\n* No significant abnormalities on history, physical examination or laboratory parameters.\n\nExclusion Criteria:\n\n* Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO.\n* Significant disease or disorder (as explained in Study B).\n* Complete bowel obstruction.\n* Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis).\n* Retroperitoneal hematomas.\n* Known GI motility disorder.\n* Underlying lung disease such as pneumonia, asthma or COPD.\n* Sepsis.\n* Planned pregnancy, already pregnant or breastfeeding.\n* Electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia).\n* Significant opioid and laxative use 4 weeks prior to surgery.\n* Anti-inflammatory use 2 days prior to surgery.\n* Drugs such as antacids, Coumadin, amitriptyline, chlorpromazine.\n* Baseline oxygen saturation \\<92% on room air.\n* Baseline blood level of COHb \\>2%.\n* Baseline hemoglobin \\<90 g/dL.\n* Participation in another clinical trial within 2 months prior to study.'}, 'identificationModule': {'nctId': 'NCT01050712', 'briefTitle': 'Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.', 'orgStudyIdInfo': {'id': 'POICO-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbon Monoxide', 'interventionNames': ['Drug: Inhaled Carbon Monoxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Synthetic Air', 'interventionNames': ['Drug: Synthetic Air']}], 'interventions': [{'name': 'Inhaled Carbon Monoxide', 'type': 'DRUG', 'description': 'Concentration of Carbon Monoxide to be inhaled by patients will be determined in a safety trial performed in healthy volunteers prior to the commencement of this trial. Patients randomized to received inhaled carbon monoxide will receive this concentration by cushioned face mask for one hour prior to colon resection and for one hour after colon resection', 'armGroupLabels': ['Carbon Monoxide']}, {'name': 'Synthetic Air', 'type': 'DRUG', 'description': 'Patients randomized to this intervention will receive this gas via cushioned face mask for one hour prior to colon resection and for one hour after colon resection', 'armGroupLabels': ['Synthetic Air']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Paul J Belliveau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Paul Belliveau', 'investigatorAffiliation': "Queen's University"}}}}