Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT03136458
Status:
WITHDRAWN
Last Update Posted:
2018-10-11
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019194', 'term': 'Ischemic Preconditioning'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No resources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast induced nephropathy incidence', 'timeFrame': '48 to 72 hours', 'description': 'Increase in serum creatinine by 0,3 mg/dL compared to initial values.'}], 'secondaryOutcomes': [{'measure': 'Adverse effects to preconditioning.', 'timeFrame': '0 to 72 hours.', 'description': 'Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['contrast media', 'nephropathy', 'ischemic preconditioning'], 'conditions': ['Contrast-induced Nephropathy']}, 'referencesModule': {'references': [{'pmid': '18178787', 'type': 'BACKGROUND', 'citation': 'Rudnick M, Feldman H. Contrast-induced nephropathy: what are the true clinical consequences? Clin J Am Soc Nephrol. 2008 Jan;3(1):263-72. doi: 10.2215/CJN.03690907.'}, {'pmid': '18987758', 'type': 'BACKGROUND', 'citation': 'Holscher B, Heitmeyer C, Fobker M, Breithardt G, Schaefer RM, Reinecke H. Predictors for contrast media-induced nephropathy and long-term survival: prospectively assessed data from the randomized controlled Dialysis-Versus-Diuresis (DVD) trial. Can J Cardiol. 2008 Nov;24(11):845-50. doi: 10.1016/s0828-282x(08)70193-4.'}, {'pmid': '15911862', 'type': 'BACKGROUND', 'citation': 'Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.'}, {'pmid': '22735307', 'type': 'BACKGROUND', 'citation': 'Bonventre JV. Limb ischemia protects against contrast-induced nephropathy. Circulation. 2012 Jul 24;126(4):384-7. doi: 10.1161/CIRCULATIONAHA.112.119701. Epub 2012 Jun 26. No abstract available.'}, {'pmid': '24309187', 'type': 'BACKGROUND', 'citation': 'Gassanov N, Nia AM, Caglayan E, Er F. Remote ischemic preconditioning and renoprotection: from myth to a novel therapeutic option? J Am Soc Nephrol. 2014 Feb;25(2):216-24. doi: 10.1681/ASN.2013070708. Epub 2013 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not.', 'detailedDescription': 'This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy, this preconditioning is administered through repeated insufflation of an arterial pressure cuff in one of the patient arms, which in theory liberates vasoactive mediators that prevents the ischemic damage to the kidneys secondary to contrast media. All of the patients will receive endovenous normal saline to prevent nephropathy, which is a common strategy in our institution. Half of the patients will receive remote ischemic preconditioning while the other half will only receive a dummy preconditioning intended to keep the double blind strategy of the trial.\n\nThe main endpoint will be to ascertain the incidence of contrast induced nephropathy in both arms of the study, as a way to evaluate the efficacy of this strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized in general wards, emergency room or ambulatory consult.\n* 18 years or older.\n* Requires computerized tomography with endovenous contrast.\n* Glomerular filtration rate between 30 - 60 mL/minute/1,73 m2.\n* Patient accepts and signs informed consent.\n\nExclusion Criteria:\n\n* Allergic to contrast media.\n* Unable to accept or sign informed consent.\n* Did not received endovenous saline before and/or after the contrast procedure.\n* Peripheral arterial disease.\n* Bilateral upper extremities lymph node dissection or any situation impending arterial pressure taking.\n* Morbid obesity (body mass index 40 or more).\n* Arterial systolic pressure greater than 175 mmHg.'}, 'identificationModule': {'nctId': 'NCT03136458', 'acronym': 'PAIR', 'briefTitle': 'Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinica Valle del Lili'}, 'officialTitle': 'Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)', 'orgStudyIdInfo': {'id': 'ValledelLili'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real ischemic preconditioning', 'description': 'Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 50 mmHg above the systolic arterial pressure of the patient.', 'interventionNames': ['Procedure: Ischemic preconditioning', 'Drug: Endovenous normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dummy ischemic preconditioning', 'description': 'Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 10 mmHg above the diastolic arterial pressure of the patient.', 'interventionNames': ['Drug: Endovenous normal saline']}], 'interventions': [{'name': 'Ischemic preconditioning', 'type': 'PROCEDURE', 'otherNames': ['remote ischemic preconditioning'], 'description': 'Repeated remote ischemic preconditioning by arterial cuff insufflation.', 'armGroupLabels': ['Real ischemic preconditioning']}, {'name': 'Endovenous normal saline', 'type': 'DRUG', 'otherNames': ['normal saline 0,9%'], 'description': 'endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.', 'armGroupLabels': ['Dummy ischemic preconditioning', 'Real ischemic preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Grupo Nefrología Fundación Valle del Lili', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Camilo Andrés Páez Angarita', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Internal Medicine Resident', 'investigatorFullName': 'Camilo Andrés Páez Angarita', 'investigatorAffiliation': 'Fundacion Clinica Valle del Lili'}}}}