Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-09 @ 2:45 AM
Study NCT ID:
NCT02357433
Status:
TERMINATED
Last Update Posted:
2018-07-06
First Post:
2015-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality Reduction in Septic Shock by Plasma Adsorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'whyStopped': 'Circumstances beyond the course of the trial have produced a change in the conditions of recruitment unacceptable to the ROMPA researchers', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2015-01-23', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital mortality', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'time resolution of septic shock', 'timeFrame': 'within the first 28 days', 'description': 'normalization of lactate, and the decrease in vasoactive drugs'}]}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '31796477', 'type': 'DERIVED', 'citation': 'Gimenez-Esparza C, Portillo-Requena C, Colomina-Climent F, Allegue-Gallego JM, Galindo-Martinez M, Molla-Jimenez C, Anton-Pascual JL, Marmol-Peis E, Dolera-Moreno C, Rodriguez-Serra M, Martin-Ruiz JL, Fernandez-Arroyo PJ, Blasco-Ciscar EM, Canovas-Robles J, Gonzalez-Hernandez E, Sanchez-Moran F, Solera-Suarez M, Torres-Tortajada J, Palazon-Bru A, Gil-Guillen VF. The premature closure of ROMPA clinical trial: mortality reduction in septic shock by plasma adsorption. BMJ Open. 2019 Dec 3;9(12):e030139. doi: 10.1136/bmjopen-2019-030139.'}, {'pmid': '27406647', 'type': 'DERIVED', 'citation': 'Colomina-Climent F, Gimenez-Esparza C, Portillo-Requena C, Allegue-Gallego JM, Galindo-Martinez M, Molla-Jimenez C, Anton-Pascual JL, Rodriguez-Serra M, Martin-Ruiz JL, Fernandez-Arroyo PJ, Blasco-Ciscar EM, Canovas-Robles J, Herrera-Murillo M, Gonzalez-Hernandez E, Sanchez-Moran F, Solera-Suarez M, Torres-Tortajada J, Nunez-Martinez JM, Martin-Langerwerf D, Herrero-Gutierrez E, Sebastian-Munoz I, Palazon-Bru A, Gil-Guillen VF. Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial. BMJ Open. 2016 Jul 12;6(7):e011856. doi: 10.1136/bmjopen-2016-011856.'}]}, 'descriptionModule': {'briefSummary': 'The study objective is to clarify whether the application of high doses CPFA (Coupled Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients admitted to the ICU in septic shock\n* all patients that develop septic shock while in the ICU\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnancy\n* Estimated life expectancy (due to comorbidities) less than 90 days\n* Presence of relative or absolute contraindications to CPFA\n* Absence of informed consen'}, 'identificationModule': {'nctId': 'NCT02357433', 'acronym': 'ROMPA', 'briefTitle': 'Mortality Reduction in Septic Shock by Plasma Adsorption', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario San Juan de Alicante'}, 'officialTitle': 'Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)', 'orgStudyIdInfo': {'id': '01-2015_R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High doses CPFA', 'description': 'High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \\>0.20 L/kg/day of plasma treated in the first 3 days after randomization', 'interventionNames': ['Device: High Doses CPFA']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Standard practice'}], 'interventions': [{'name': 'High Doses CPFA', 'type': 'DEVICE', 'armGroupLabels': ['High doses CPFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03293', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Vinalopó', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '03300', 'city': 'Orihuela', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de la Vega Baja', 'geoPoint': {'lat': 38.08483, 'lon': -0.94401}}, {'zip': '03550', 'city': "Sant Joan d'Alacant", 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario de San Juan de Alicante', 'geoPoint': {'lat': 38.40148, 'lon': -0.43623}}, {'zip': '03186', 'city': 'Torrevieja', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Torrevieja', 'geoPoint': {'lat': 37.97872, 'lon': -0.68222}}, {'city': 'Villajoyosa', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Marina Baixa', 'geoPoint': {'lat': 38.50754, 'lon': -0.23346}}, {'zip': '12540', 'city': 'Villarreal', 'state': 'Castellon', 'country': 'Spain', 'facility': 'Hospital de la Plana', 'geoPoint': {'lat': 38.72572, 'lon': -7.21533}}, {'zip': '30202', 'city': 'Cartagena', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital General Universitario de Santa Lucia', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'city': 'Gandia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Frances De Borja de Gandia', 'geoPoint': {'lat': 38.96667, 'lon': -0.18333}}, {'zip': '46800', 'city': 'Xátiva', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Lluis Alcanyis'}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'overallOfficials': [{'name': 'Francisco Colomina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de San Juan de Alicante'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Francisco Colomina Climent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Francisco Colomina Climent', 'investigatorAffiliation': 'Hospital Universitario San Juan de Alicante'}}}}