Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02609360
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2015-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2015-11-07', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in Acid-Base Equilibrium (Base Excess)', 'timeFrame': 'First 24 hours after ECMO start'}], 'secondaryOutcomes': [{'measure': 'Variation in Acid-Base Equilibrium (pH)', 'timeFrame': 'First 24 hours after ECMO start'}, {'measure': 'Variation in Renal Function', 'timeFrame': 'First 24 hours after ECMO start'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Failure', 'ARDS', 'ECMO', 'Lung transplantation', 'Acid-Base Equilibrium'], 'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': "Crystalloid solutions modify acid-base equilibrium according to their electrolyte composition. Moreover, it has been suggested that these alterations are generated by the difference between the solution strong ion difference (SID) and the plasma bicarbonate level. An increased risk of acute kidney injury and renal replacement therapy has been associated to the infusion of chloride rich crystalloids. This study aims to compare, in patients with acute respiratory failure undergoing ECMO support, the effects on acid-base status and renal function of crystalloids commonly employed for circuit priming to a balanced solution created with a SID equal to patients' bicarbonate level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Acute Respiratory Failure in need for ECMO treatment\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02609360', 'briefTitle': 'Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming', 'orgStudyIdInfo': {'id': '1897'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.9% NaCl', 'description': 'Circuit priming will be performed with 0.9% NaCl solution', 'interventionNames': ['Other: Priming of ECMO circuit with 0.9% NaCl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ringer Lactate', 'description': 'Circuit priming will be performed with Ringer Lactated', 'interventionNames': ['Other: Priming of ECMO circuit with Ringer Lactate']}, {'type': 'EXPERIMENTAL', 'label': 'Balanced Solution', 'description': "Circuit priming will be performed with a Balanced Solution created by mixing 0.9% NaCl, Sodium bicarbonate (8.4%) and injectable sterile water, in order to obtain a solution with constant sodium concentration (140 mEq/l) and SID equal to patient's bicarbonate level.", 'interventionNames': ['Other: Priming of ECMO circuit with Balanced Solution']}], 'interventions': [{'name': 'Priming of ECMO circuit with 0.9% NaCl', 'type': 'OTHER', 'description': '0.9% NaCl as priming crystalloid solution', 'armGroupLabels': ['0.9% NaCl']}, {'name': 'Priming of ECMO circuit with Ringer Lactate', 'type': 'OTHER', 'description': 'Ringer Lactate as priming crystalloid solution', 'armGroupLabels': ['Ringer Lactate']}, {'name': 'Priming of ECMO circuit with Balanced Solution', 'type': 'OTHER', 'description': 'Balanced Solution as priming crystalloid solution', 'armGroupLabels': ['Balanced Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Caironi, MD', 'role': 'CONTACT', 'email': 'pietro.caironi@unimi.it', 'phone': '+39-02-55033232'}], 'facility': "Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Pietro Caironi, MD', 'role': 'CONTACT', 'email': 'pietro.caironi@unimi.it', 'phone': '+39-02-55033232'}], 'overallOfficials': [{'name': 'Pietro Caironi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}