Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT07000994
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dobutamine During Major Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004280', 'term': 'Dobutamine'}], 'ancestors': [{'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Severe tachyarrhythmias', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Incidence of severe tachyarrhythmias (severe tachycardia defined as a heart rate \\>120 beats per minute or new abnormal heart rhythms)'}, {'measure': 'Blood loss', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Estimated blood loss \\[mL\\]'}, {'measure': 'Amount of fluids', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Total amount of fluid administration divided by surgical duration \\[mL h-1\\]'}, {'measure': 'Red blood cell transfusion', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Red blood cell transfusion requirements \\[units\\]'}, {'measure': 'Urine output', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Total urine output divided by surgical duration \\[mL h-1\\]'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Assessed up to 3 months', 'description': 'Hospital length of stay \\[days\\]'}, {'measure': 'Rehospitalization', 'timeFrame': 'Within 30 days after surgery', 'description': 'Rehospitalization within 30 days after surgery (assessed based on electronic health records and/or telephone interviews)'}, {'measure': 'Postoperative complications', 'timeFrame': 'Within 30 days after surgery', 'description': 'Incidence of postoperative complications (assessed based on electronic health records and/or telephone interviews): acute myocardial infarction, acute kidney injury, stroke, surgical site infection, sepsis, infection requiring antibiotic treatment, renal replacement therapy, non-fatal cardiac arrest, and death'}], 'primaryOutcomes': [{'measure': 'Feasibility of dobutamine administration', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'The primary outcome "feasibility of dobutamine administration" is defined as dobutamine administration during \\>70% of surgery duration in \\>80% of all patients.'}], 'secondaryOutcomes': [{'measure': 'Arterial hypotension', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Time-weighted average mean arterial pressure below 65 mmHg \\[mmHg\\]'}, {'measure': 'Stroke volume index', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Median stroke volume index \\[mL m-2\\]'}, {'measure': 'Heart rate', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Median heart rate \\[beats per minute\\]'}, {'measure': 'Cardiac index', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Median cardiac index during surgery \\[L min-1 m-2\\]'}, {'measure': 'Norepinephrine amount', 'timeFrame': 'During surgery (incision-to-suture)', 'description': 'Total amount of administered norepinephrine divided by body weight and surgical duration \\[µg kg-1 min-1\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Myocardial Depression']}, 'descriptionModule': {'briefSummary': 'The PUSH-1 trial is a randomized, single-center pilot trial investigating whether dobutamine administration is feasible in patients having major abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting patients ≥18 years scheduled for elective major abdominal surgery under general anesthesia (expected surgery duration ≥ 120 minutes)\n* Planned continuous intraarterial blood pressure monitoring using an arterial catheter for clinical indications not related to the trial\n\nExclusion Criteria:\n\n* Emergency surgery\n* Liver or kidney transplantation surgery\n* Status of post transplantation of kidney, liver, heart, or lung\n* Pregnancy\n* Heart rhythms other than sinus rhythm'}, 'identificationModule': {'nctId': 'NCT07000994', 'acronym': 'PUSH-1', 'briefTitle': 'Dobutamine During Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Hamburg-Eppendorf'}, 'officialTitle': 'Dobutamine During Major Abdominal Surgery: A Randomized Pilot Trial (PUSH-1)', 'orgStudyIdInfo': {'id': '2022-100915-BO-ff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dobutamine administration', 'description': 'In patient assigned to dobutamine administration, dobutamine (concentration: 5 mg mL-1) will be administered with an infusion rate of 3 µg kg-1 min-1 (ideal body weight).\n\nDobutamine administration will start with the beginning of surgery and will end after the end of surgery (incision-to-suture). The treating anesthesiologist may increase or stop dobutamine administration if clinically indicated. Whenever dobutamine-induced tachycardia (defined as a heart rate ≥120 beats per minute) or new-onset cardiac arrhythmia is noted, dobutamine administration will be stopped. Restarting dobutamine administration is at the discretion of the treating anesthesiologist.', 'interventionNames': ['Drug: Dobutamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine care', 'description': 'In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care.', 'interventionNames': ['Other: Routine care']}], 'interventions': [{'name': 'Dobutamine', 'type': 'DRUG', 'description': 'In patient assigned to dobutamine administration, dobutamine (concentration: 5 mg mL-1) will be administered with an infusion rate of 3 µg kg-1 min-1 (ideal body weight).', 'armGroupLabels': ['Dobutamine administration']}, {'name': 'Routine care', 'type': 'OTHER', 'description': 'In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care.', 'armGroupLabels': ['Routine care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alina Bergholz, MD', 'role': 'CONTACT', 'email': 'a.bergholz@uke.de', 'phone': '+4940 7410 0'}, {'name': 'Karim Kouz, MD', 'role': 'CONTACT'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Alina Bergholz, MD', 'role': 'CONTACT', 'email': 'a.bergholz@uke.de', 'phone': '+49 40 7410 0'}, {'name': 'Bernd Saugel, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Alina Bergholz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Alina Bergholz', 'investigatorAffiliation': 'University of Hamburg-Eppendorf'}}}}