Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT04231994
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2020-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Plasmaexchange in Early Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-06', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Norepinephrine dose', 'timeFrame': '6 hours after randomization', 'description': 'Vasopressor dose reduction as indicator of shock reversal'}], 'secondaryOutcomes': [{'measure': 'Mean Sequential organ failure assessment (SOFA) score', 'timeFrame': 'day 1-8 following randomization', 'description': 'SOFA score as indicator of organ dysfunction'}, {'measure': 'percent change of ADAMTS-13 activity from baseline', 'timeFrame': '6 hours after randomization', 'description': '(will only be analyzed in the Hannover cohort)'}, {'measure': 'percent change of activated Protein C activity from baseline', 'timeFrame': '6 hours after randomization', 'description': '(will only be analyzed in the Hannover cohort)'}, {'measure': 'percent change of permeability factors angiopoietin-1, -2 and sTie-2 from baseline', 'timeFrame': '6 hours after randomization', 'description': 'permeability and anti-permeability factors (will only be analyzed in the Hannover cohort)'}, {'measure': '28 day survival', 'timeFrame': 'after 28 days following randomization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Septic shock', 'Therapeutic plasma exchange', 'Sepsis'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '33471132', 'type': 'RESULT', 'citation': 'David S, Bode C, Putensen C, Welte T, Stahl K; EXCHANGE study group. Adjuvant therapeutic plasma exchange in septic shock. Intensive Care Med. 2021 Mar;47(3):352-354. doi: 10.1007/s00134-020-06339-1. Epub 2021 Jan 20. No abstract available.'}, {'pmid': '35551628', 'type': 'DERIVED', 'citation': 'Stahl K, Wand P, Seeliger B, Wendel-Garcia PD, Schmidt JJ, Schmidt BMW, Sauer A, Lehmann F, Budde U, Busch M, Wiesner O, Welte T, Haller H, Wedemeyer H, Putensen C, Hoeper MM, Bode C, David S. Clinical and biochemical endpoints and predictors of response to plasma exchange in septic shock: results from a randomized controlled trial. Crit Care. 2022 May 12;26(1):134. doi: 10.1186/s13054-022-04003-2.'}, {'pmid': '34817751', 'type': 'DERIVED', 'citation': 'Stahl K, Hillebrand UC, Kiyan Y, Seeliger B, Schmidt JJ, Schenk H, Pape T, Schmidt BMW, Welte T, Hoeper MM, Sauer A, Wygrecka M, Bode C, Wedemeyer H, Haller H, David S. Effects of therapeutic plasma exchange on the endothelial glycocalyx in septic shock. Intensive Care Med Exp. 2021 Nov 24;9(1):57. doi: 10.1186/s40635-021-00417-4.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33471132/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (\\> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (\\< 24 hrs) and high catecholamine doses (norepinephrine \\> 0.4 ug/kg body weight/min) will be included. Those in the treatment group will receive 1 TPE within 2 hours following randomization. The primary outcome is norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be performed at the Hannover medical School University hospital in Germany. Secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after TPE.\n\nThe investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Onset of septic shock within less than 24 hrs\n* Norepinephrine dose of ≥ 0.4 ug/kg/min bodyweight (target mean arterial pressure ≥ 65 mmHg) ≥ 30 min\n\nExclusion Criteria:\n\n* Age\\<18 years and \\> 80 years\n* Pregnancy\n* Known history of transfusion reactions'}, 'identificationModule': {'nctId': 'NCT04231994', 'acronym': 'EXCHANGE', 'briefTitle': 'Therapeutic Plasmaexchange in Early Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Prospective, Randomized, Single-center, Open-label, Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy Against Early Septic Shock - Effect on Hemodynamics and Biochemical Markers', 'orgStudyIdInfo': {'id': 'EXCHANGE 2786-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TPE', 'description': 'additive singular therapeutic plasma Exchange (TPE) using fresh frozen Plasma (FFP) as replacement fluid', 'interventionNames': ['Device: TPE']}, {'type': 'NO_INTERVENTION', 'label': 'SMT', 'description': 'Standard medical Treatment (SMT) for septic shock following the present surviving sepsis guidelines'}], 'interventions': [{'name': 'TPE', 'type': 'DEVICE', 'description': 'singular Therapeutic Plasma Exchange using fresh frozen Plasma as replacement fluid', 'armGroupLabels': ['TPE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'overallOfficials': [{'name': 'Sascha David, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for nephrology'}, {'name': 'Klaus Stahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for gastroenterology and hepatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'pre-defined substudies'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Klaus Stahl, Fellow Gastroenterology and Critical Care Medicine', 'investigatorFullName': 'Stahl, Klaus Dr.', 'investigatorAffiliation': 'Hannover Medical School'}}}}