Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 4:47 PM
Study NCT ID:
NCT07186634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PeRiOperative Medicine Platform Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen concentration'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7800}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost Analysis', 'timeFrame': '30 days', 'description': 'Direct health care costs at 30 days after index surgery Number of quality-adjusted life years (QALYs) at 30 days after index surgery Cost effectiveness measured as a cost per QALY.'}], 'primaryOutcomes': [{'measure': 'Surgical Site Infection', 'timeFrame': '30 days', 'description': 'A post operative infection that develops at the site of an operation, caused by bacteria entering the body through the surgical incision'}], 'secondaryOutcomes': [{'measure': 'Health Care Associated Infections', 'timeFrame': '30 days', 'description': 'pneumonia, blood stream infection and urinary tract infection'}, {'measure': 'Quality of recovery', 'timeFrame': '3 and 30 days after surgery', 'description': "Quality of the individual's recovery post surgery - PROM. The scores of all 15 questions, with each item rated on a scale that results in a total score ranging from 0 (very poor recovery) to 150 (excellent recovery)"}, {'measure': 'major postoperative complications', 'timeFrame': '30 days', 'description': 'Description: A composite (and individually): Cardiovascular events (myocardial infarction, arterial or venous thrombosis, stroke, acute pulmonary edema, cardiogenic shock, new cardiac arrhythmia requiring treatment) Sepsis or septic shock (defined according to the Sepsis-3 definition)25 Respiratory complications - (i) pneumonia using US Centers for Disease Control criteria, (ii) Acute Respiratory Distress Syndrome using Berlin consensus definition, or (iii) the need for tracheal re-intubation and mechanical ventilation after extubation, and within 30 days after surgery OR mechanical ventilation for more than 24 h after surgery26 Unplanned intensive care unit (ICU) admission or readmission, defined as not anticipated preoperatively Acute kidney injury (based on the serum creatinine item of the Kidney Disease Improving Global Outcome criteria) Need for surgical re-intervention within 30 days after surgery Death within 30 days after surgery. Time Frame: 30 days'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'All cause'}, {'measure': 'EQ-5D-5L', 'timeFrame': '30 days', 'description': 'Quality of life (EQ-5D-5L) at 30 days after index surgery. The resulting EQ-5D index score is a numerical value, with 1 representing full health, and scores less than 1 representing poorer health states, including negative values that indicate health states worse than death.'}, {'measure': 'DAH 30', 'timeFrame': '30 days', 'description': "Days alive and at home at 30 days (DAH30) after index surgery (reflecting the patient's primary aim of a healthy recovery, reduced hospital costs and the impact/severity of serious complications, and avoiding re-admission (often due to SSI)."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anaesthesiology, complications, oxygen, surgery', 'platform trial'], 'conditions': ['Surgical Site Infection After Major Surgery', 'Anaesthesia', 'Major Complications', 'Quality of Recovery (QoR-15)', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or "wound infections") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases "days alive and at home up to 30 days after surgery" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.', 'detailedDescription': 'www.promptssi.org.au'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROMPT - Inclusion Criteria:\n\n* Adult patient (≥18 years of age at time of admission)\n* Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).\n\nPROMPT - Exclusion Criteria:\n\n* ASA physical status 5 (moribund, not expected to survive with or without an operation)\n* Inability to provide informed consent\n* Previous participation in PROMPT within the prior 30 days.\n\nDSA 02 - PROMPT - Exclusion Criteria:\n\n* ASA physical status 1 or 2\n* Undergoing cardiac surgery\n* Undergoing thoracic surgery if one-lung ventilation is required\n* Currently suspected or proven infection\n* Advanced lung disease requiring home oxygen therapy\n* Previous bleomycin therapy\n* Known or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT07186634', 'acronym': 'PROMPT', 'briefTitle': 'PeRiOperative Medicine Platform Trial', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Domain-Specific Appendix: OXYGEN', 'orgStudyIdInfo': {'id': '2025-49324-130781'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal inspired oxygen', 'description': 'FiO2 0.8; i.e. 80%', 'interventionNames': ['Drug: Liberal inspired oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative inspired oxygen', 'description': 'FiO2 ≤0.3 \\[30%\\]', 'interventionNames': ['Drug: Conservative inspired oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermediate inspired oxygen', 'description': 'FiO2 0.5 \\[50%\\]', 'interventionNames': ['Drug: Intermediate inspired oxygen']}], 'interventions': [{'name': 'Liberal inspired oxygen', 'type': 'DRUG', 'description': 'The concentration of Oxygen will differ according to the randomisation', 'armGroupLabels': ['Liberal inspired oxygen']}, {'name': 'Conservative inspired oxygen', 'type': 'DRUG', 'description': 'Conservative inspired oxygen', 'armGroupLabels': ['Conservative inspired oxygen']}, {'name': 'Intermediate inspired oxygen', 'type': 'DRUG', 'description': 'Intermediate inspired oxygen', 'armGroupLabels': ['Intermediate inspired oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Paul S Myles, DSc', 'role': 'CONTACT', 'email': 'p.myles@alfred.org.au', 'phone': '61390762000', 'phoneExt': '63176'}], 'facility': 'The Alfred', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Paul S Myles, DSc', 'role': 'CONTACT', 'email': 'p.myles@alfred.org.au', 'phone': '+6190762000', 'phoneExt': '63176'}, {'name': 'Trisha Peel, PhD', 'role': 'CONTACT', 'email': 'trisha.peel@monash.edu', 'phone': '+61 3 9076 5436'}], 'overallOfficials': [{'name': 'Paul s Myles, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Trisha Peel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Daniel Frei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wellington Reginal Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Dependent on Ethics Committee (IRB) approval, a clinically important hypothesis and valid protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Alfred', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}