Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT03229694
Status:
UNKNOWN
Last Update Posted:
2017-07-25
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Tracleer on Tourniquet-associated Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D065128', 'term': 'Endothelin Receptor Antagonists'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-22', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-22', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum rate of change in systolic blood pressure (MR)', 'timeFrame': '24 hours after surgery', 'description': 'During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure'}], 'secondaryOutcomes': [{'measure': 'the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine', 'timeFrame': 'baseline and intraoperative', 'description': 'test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point'}, {'measure': 'visual analog scale', 'timeFrame': '24 hrs after surgery', 'description': 'assess the efficacy of analgesia using visual analog scale (VAS)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tourniquets', 'Hypertension', 'Bosentan']}, 'descriptionModule': {'briefSummary': 'Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension. Thus, to effectively prevent the tourniquet related hemodynamic responses is important for patients receiving limb surgery.\n\nTracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present trial, the investigators are going to investigate the effect of Tracleer on tourniquet-associated hypertension during total knee arthroplasty.', 'detailedDescription': 'At present study, the investigators will use endothelin receptor antagonist, Tracleer (Bosentan), to investigate the effect of Tracleer on tourniquet-associated hypertension during unilateral total knee arthroplasty, and evaluate its safety and effectivity. The purpose of this study is to find a new therapy to prevent and treat tourniquet-associated hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent selected total knee arthroplasty under general anesthesia\n* ASA II-III\n* 18\\~65 years old\n* Signed informed consent voluntarily\n\nExclusion Criteria:\n\n* Do not apply tourniquet during the surgery\n* Patients underwent emergency surgery\n* Having applied tourniquet in last three months\n* Patients underwent bilateral total knee arthroplasty\n* Dysfunction of liver or kidney\n* Anemia (Hb \\<90 g/L)\n* Serious myocardial disease (eg. coronary heart disease, heart failure, severe arrhythmia)\n* Coagulation disorder\n* Diabetic\n* Leukocyte higher than normal value\n* Pneumonia, asthma, chronic obstructive pulmonary disease\n* Hypotension before surgery (systolic pressure \\< 90 mmHg)\n* Pregnant woman or puerpera\n* Having being enrolled in other clinical trial in last 3 months'}, 'identificationModule': {'nctId': 'NCT03229694', 'briefTitle': 'the Effect of Tracleer on Tourniquet-associated Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Xuzhou Medical University'}, 'officialTitle': 'Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'XYFY-2017-068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tracleer (or Bosentan)', 'description': 'Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery', 'interventionNames': ['Drug: Tracleer 125Mg Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was administered orally at two hours before surgery and six hours after surgery', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tracleer 125Mg Tablet', 'type': 'DRUG', 'otherNames': ['Bosentan', 'endothelin receptor antagonist'], 'description': 'Tracleer was administered orally at two hours before surgery and six hours after surgery.', 'armGroupLabels': ['Tracleer (or Bosentan)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo was administered orally at two hour before surgery and six hours after surgery.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Jiang Cao, doctor', 'role': 'CONTACT', 'email': 'xyfyll2297@163.com', 'phone': '+86-516-85802291'}], 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Jiang Cao, professor', 'role': 'CONTACT', 'email': 'xyfyll2297@163.com', 'phone': '+86-516-85802291'}], 'overallOfficials': [{'name': 'Su Liu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Xuzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associtate professor', 'investigatorFullName': 'Su Liu', 'investigatorAffiliation': 'Xuzhou Medical University'}}}}