Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 1:31 AM
Study NCT ID:
NCT04235634
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2020-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000527', 'term': 'Alprostadil'}], 'ancestors': [{'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of ischemia', 'timeFrame': '24 hours following intervention', 'description': 'Lactate reduction \\> 2mmol/l from baseline'}], 'secondaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days following intervention', 'description': 'key secondary outcome'}, {'measure': 'Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours', 'timeFrame': '24 hours following intervention', 'description': 'as indicator of Shock reversal'}, {'measure': 'simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI', 'timeFrame': 'immediately following first intra-arterial bolus', 'description': 'angiographic characteristics of vasodilation following Initial Prostaglandin bolus'}, {'measure': 'peak density (PD) as measured by 2D perfusion angiography', 'timeFrame': 'immediately following first intra-arterial bolus', 'description': 'angiographic characteristics of vasodilation following Initial Prostaglandin bolus'}, {'measure': 'area under the curve (AUC) as measured by 2D perfusion angiography', 'timeFrame': 'immediately following first intra-arterial bolus', 'description': 'angiographic characteristics of vasodilation following Initial Prostaglandin bolus'}, {'measure': 'time to peak (TTP) as measured by 2D perfusion angiography', 'timeFrame': 'immediately following first intra-arterial bolus', 'description': 'angiographic characteristics of vasodilation following Initial Prostaglandin bolus'}, {'measure': 'intestinal fatty acid-binding protein (I-FABP), smooth muscle protein of 22kDa (SM22) liver fatty acid-binding protein (L-FABP)', 'timeFrame': '24 hours following intervention', 'description': 'markers of ischemic intestinal barrier dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-occlusive mesenteric ischemia', 'Shock', 'Intra-arterial prostglandin therapy'], 'conditions': ['Non-Occlusive Mesenteric Ischaemia (NOMI)']}, 'referencesModule': {'references': [{'pmid': '35379286', 'type': 'DERIVED', 'citation': 'Rittgerodt N, Pape T, Busch M, Becker LS, Schneider A, Wedemeyer H, Seeliger B, Schmidt J, Hunkemoller AM, Fuge J, Knitsch W, Fegbeutel C, Gillmann HJ, Meyer BC, Hoeper MM, Hinrichs JB, David S, Stahl K. Predictors of response to intra-arterial vasodilatory therapy of non-occlusive mesenteric ischemia in patients with severe shock: results from a prospective observational study. Crit Care. 2022 Apr 4;26(1):92. doi: 10.1186/s13054-022-03962-w.'}]}, 'descriptionModule': {'briefSummary': 'Minimal invasive intra-arterial prostaglandin therapy is currently being offered as an established and safe treatment approach for Non-occlusive mesenteric ischemia (NOMI). So far, there are no data that prospective evaluate clinical response parameters of this method and corresponding criteria for response.\n\nThe investigators are therefore planning a prospective observational study on NOMI patients with the aim to collect\n\n1. routine clinical data,\n2. data from advanced angigraphic imaging and\n3. data from blood biomarkers of intestinal ischemia before/at implementation of intra-arterial vasodilatory therapy.\n\nFrom these three data packages, the investigators hope to subsequentially derive criteria to better predict response to therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the ICU with persistent shock, intestinal failure as well as new onset and progressive organ failure with a CT and angiography based diagnosis of Non-occlusive mesenteric ischemia (NOMI)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- persistent shock: Norepinephrine dose \\> 0.2ug/kg/min over \\> 48hrs\n\nand\n\n* intestinal failure: paralytic ileus \\> 24hrs despite neostigmine therapy or\n* new onset progressive organ failure (2 out of six criteria): Norepinephrine dose increase, rise in serum lactate, decrease in Horowitz index, new renal replacement therapy, rise in bilirubin, rise in INR, or all of the following: rise in ALT, AST, CK and LDH\n\nExclusion Criteria:\n\n* patients \\< 18 years old\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04235634', 'acronym': 'REPERFUSE', 'briefTitle': 'Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)', 'orgStudyIdInfo': {'id': 'REPERFUSE_8092_BO_S_2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intra-arterial Prostglandin therapy', 'description': 'Minimal invasive Cannulation of the Superior Mesenteric Artery (SMA) and subsequent intra-arterial application of prostaglandin E1 (Initial Bolus 20ug, followed by continuous Infusion of 60-80ug/24hr for 24-72hrs)', 'interventionNames': ['Drug: Prostavasin']}], 'interventions': [{'name': 'Prostavasin', 'type': 'DRUG', 'description': 'Minimal invasive Cannulation of the Superior Mesenteric Artery (SMA) and subsequent intra-arterial application of prostaglandin E1 (Initial Bolus 20ug, followed by continuous Infusion of 60-80ug/24hr for 24-72hrs)', 'armGroupLabels': ['Intra-arterial Prostglandin therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Markus Busch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for gastroenterology and hepatology'}, {'name': 'Klaus Stahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for nephrology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}