Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05996120
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2023-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel group, open label, statistician blinded, multicentre, randomised controlled feasibility trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2023-07-02', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Data completeness', 'timeFrame': '6 months', 'description': 'Data recorded on HealthBitⓇ will be assessed for percentage of completion'}, {'measure': 'Attrition rate', 'timeFrame': '6 months', 'description': 'For ascertainment of the primary outcome and for planning of future large-scale study'}, {'measure': 'User satisfaction of ResearchApp', 'timeFrame': '6 months', 'description': 'Participants will be invited to complete optional survey on user satisfaction of ResearchApp'}], 'primaryOutcomes': [{'measure': 'Total number of participants recruited over a 6 month period', 'timeFrame': '6 months', 'description': 'The target recruitment rate is 1 participant per week per centre. The feasibility trial will be considered positive if 80% of target met, together with outcome 2.'}, {'measure': 'Adherence rate to allocation', 'timeFrame': '6 months', 'description': 'The feasibility trial will be considered positive if 74%\\* of target adherence to trial allocation is met, together with outcome 1.\n\n\\*74% is derived from 80% of target adherence of 92% as per Warm Heart Study'}], 'secondaryOutcomes': [{'measure': 'Incidence of 6-week composite endpoint of Major Adverse Cardiac and Cerebrovascular Events (MACCE)', 'timeFrame': '6 weeks', 'description': 'MACCE is defined as any post-operative death, stroke, new intra-aortic balloon pump insertion, new renal replacement therapy, re-operation and major bleeding in this feasibility trial.'}, {'measure': 'Incidence of deep sternal wound infection, with or without treatment', 'timeFrame': '6 weeks', 'description': 'Deep sternal wound infection is defined with at least one of the following criteria:\n\n(I) an organism is isolated from culture of mediastinal tissue or fluid (II) evidence of mediastinitis seen intraoperatively (III) presence of chest pain, sternal instability, or fever (\\> 38 °C), and purulent drainage from the mediastinum or isolation of organism present in a blood culture or from the mediastinal area.'}, {'measure': 'Incidence of all adverse events', 'timeFrame': '6 weeks', 'description': 'Composite of all reported adverse events. Examples of adverse events include: low cardiac output, suspected myocardial infarction, arrhythmias, infections, haemorrhage, and pulmonary embolus.'}, {'measure': 'Critical care length of stay', 'timeFrame': '6 weeks', 'description': 'Number of days a participant is admitted in cardiac critical care unit'}, {'measure': 'Post-operative length of stay', 'timeFrame': '6 weeks', 'description': 'Number of days a participant is an in-patient after index operation'}, {'measure': 'Frequency of post-discharge healthcare resource utilisation', 'timeFrame': '6 weeks', 'description': 'Number of visits to general practitioner (GP) and/or hospital, either district general hospital or tertiary hospital, will be recorded via HealthBitⓇ.'}, {'measure': 'Quality of life post-operation: Medical Outcomes Study Short-Form 36 (SF-36)', 'timeFrame': '6 weeks', 'description': 'Quality of life questionnaire (SF-36) will administered before surgery and at 6-week follow up'}, {'measure': 'Quality of life post-operation: European Quality of Life-5 Dimensions (EQ-5D)', 'timeFrame': '6 weeks', 'description': 'Quality of life questionnaire (EQ-5D) will administered before surgery and at 6-week follow up'}, {'measure': 'Quality of life post-operation: World Health Organisation Disability Assessment Schedule (WHODAS)', 'timeFrame': '6 weeks', 'description': 'Quality of life questionnaire (WHODAS) will administered before surgery and at 6-week follow up'}, {'measure': 'Clinical Frailty Scale (CFS) post-operation', 'timeFrame': '6 weeks', 'description': 'Clinical Frailty Scale will be recorded before surgery and at 6-week follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiopulmonary bypass', 'hypothermia', 'myocardial protection', 'neurologic protection'], 'conditions': ['Ischemic Heart Disease', 'Valvular Heart Disease', 'Cardiovascular Diseases', 'Surgery-Complications']}, 'descriptionModule': {'briefSummary': 'In order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs.\n\nHistorically, when a patient is connected to CPB, their body is cooled below the normal body temperature. This is known as hypothermia. This is because scientific studies have previously shown that reduced body temperature lowers metabolism and therefore offers more protection to the brain and other organs due to the reduced oxygen requirement. The evidence supporting this practice, however, has been challenged throughout the history of cardiac surgery, with studies supporting that normothermia, or normal body temperature, is a safe alternative. Despite this, the practice of hypothermia has persisted. Published data from a survey of 139 cardiac surgeons in the United Kingdom showed that 84% still routinely employ hypothermic CPB during surgery.\n\nTo assess whether normothermic or hypothermic CPB is safer, a clinical trial requiring a large sample size and high recruitment rates will be required. Therefore, the investigators aim to assess firstly the feasibility of trial recruitment and allocation adherence in this study. 100 adults across 10 different cardiac surgery centres in the United Kingdom will be recruited to a multicentre feasibility randomised controlled trial comparing normothermia (active comparator) against hypothermia (control comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.', 'detailedDescription': 'Primary Objective\n\nTo assess the feasibility of trial recruitment and delivery to target in the United Kingdom of a multicentre randomised controlled trial on normothermia versus hypothermia during cardiopulmonary bypass in adult cardiac surgery.\n\nSecondary Objective\n\nTo assess the feasibility of conducting a multicentre randomized controlled trial (RCT) using a novel Good Clinical Practice (GCP) approved remote data capture as the primary trial database alongside analysis of routinely collected healthcare data.\n\nTo obtain pilot data, undertaken by the Cardiothoracic Interdisciplinary Research Network (CIRN), to inform a subsequent large, adequately powered RCT for optimal temperature management during CPB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nParticipants may enter the trial if all of the following apply\n\n1. Adult patients (≥ 18 years) scheduled for coronary artery bypass surgery and/or valve replacement/ repair, either in the elective or urgent setting.\n2. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.\n3. Able to understand and communicate to provide informed consent.\n4. Able to read and understand the English language.\n\nEXCLUSION CRITERIA\n\nParticipants may not enter the trial if any of the following apply:\n\n1. Patients undergoing coronary artery bypass surgery in combination with other procedures including cardiac or vascular procedures that require deep hypothermic arrest.\n2. Patients undergoing emergency or salvage surgery.\n3. Patients undergoing off-pump cardiac surgery.\n4. Patients who are participating in another interventional trial.\n5. Unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05996120', 'acronym': 'THERMIC-4', 'briefTitle': 'Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leicester'}, 'officialTitle': 'Normothermic Versus Hypothermic Cardiopulmonary Bypass in Adult Cardiac Surgery: a Multicentre Feasibility Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '0910'}, 'secondaryIdInfos': [{'id': 'IRAS', 'type': 'OTHER', 'domain': '325522'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypothermic Cardiopulmonary Bypass', 'description': 'Patients allocated to this arm will undergo standard care for coronary artery bypass grafting and/or valve surgery with mild hypothermia during CPB.', 'interventionNames': ['Procedure: Hypothermic Cardiopulmonary Bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normothermic Cardiopulmonary Bypass', 'description': 'Patients allocated to this arm will undergo intervention care for coronary artery bypass grafting and/or valve surgery with normothermia hypothermia during CPB.', 'interventionNames': ['Procedure: Normothermic Cardiopulmonary Bypass']}], 'interventions': [{'name': 'Hypothermic Cardiopulmonary Bypass', 'type': 'PROCEDURE', 'description': 'Mild hypothermia (between 32 - 35 °C) during cardiopulmonary bypass', 'armGroupLabels': ['Hypothermic Cardiopulmonary Bypass']}, {'name': 'Normothermic Cardiopulmonary Bypass', 'type': 'PROCEDURE', 'description': 'Normothermia (active maintenance of temperature between 36.5 °C to 37.5°C; no active cooling below 36.5 °C) during cardiopulmonary bypass', 'armGroupLabels': ['Normothermic Cardiopulmonary Bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE3 9QP', 'city': 'Leicester', 'state': 'Leicestershire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ann Cheng', 'role': 'CONTACT', 'email': 'ann.cheng1@nhs.net'}], 'facility': 'Glenfield Hospital, University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Marcus Taylor', 'role': 'CONTACT', 'email': 'marcus.taylor1@nhs.net'}], 'facility': 'Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BS1 3NU', 'city': 'Bristol', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Luke Rogers', 'role': 'CONTACT', 'email': 'ljrogers@doctors.org.uk'}], 'facility': 'University Hospitals Bristol and Weston NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mohamed Sherif', 'role': 'CONTACT', 'email': 'mohamed.sherif3@nhs.net'}], 'facility': 'Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'G81 4DY', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital, NHS Golden Jubilee', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SE5 9RS', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Naomi Watson', 'role': 'CONTACT', 'email': 'naomi.watson5@nhs.net'}], 'facility': "King's College Hospital, King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6NP', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ricky Vaja', 'role': 'CONTACT', 'email': 'r.vaja@rbht.nhs.uk'}], 'facility': "Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'UB9 6JH', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': "Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ali Ansaripour', 'role': 'CONTACT', 'email': 'ali.ansaripou@ouh.nhs.uk'}], 'facility': 'John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Omar Zibdeh', 'role': 'CONTACT', 'email': 'o.zibdeh@nhs.net'}], 'facility': 'Derriford Hospital, Plymouth University Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Olaniran Omodara', 'role': 'CONTACT', 'email': 'olaniran.omodara@nhs.net'}], 'facility': 'Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'centralContacts': [{'name': 'Gavin J Murphy, FRCS, MD, MBChB, BSc', 'role': 'CONTACT', 'email': 'gjm19@le.ac.uk', 'phone': '0116 258 3054'}, {'name': 'Ann Cheng, MBChB, MSc', 'role': 'CONTACT', 'email': 'ann.cheng1@nhs.net'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'The investigators will retain the fully anonymised dataset indefinitely. The duration for which this will be shared will be determined on a case-by-case basis and defined in a Data Sharing Agreement.', 'ipdSharing': 'YES', 'description': 'Fully anonymised individual participant data can be made available on request for future studies with ethics approval.', 'accessCriteria': 'Requests must be from studies with appropriate ethics approval in place.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leicester', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS National Waiting Times Centre Board', 'class': 'OTHER'}, {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, {'name': 'University Hospitals Bristol and Weston NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University Hospitals, Leicester', 'class': 'OTHER'}, {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}