Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 11:01 PM
Study NCT ID:
NCT01260259
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2010-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seattle Cardiorenal Remote Ischemic Preconditioning Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute kidney injury (AKI)', 'timeFrame': '72 hours', 'description': 'Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.'}, {'measure': 'Incidence of acute myocardial injury', 'timeFrame': '48 hours', 'description': 'Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute lung injury', 'timeFrame': '72 hours and duration of hospitalization', 'description': 'Days on mechanical ventilation, readiness for extubation.'}, {'measure': 'Hospitalization', 'timeFrame': 'Duration of post-operative hospitalization', 'description': 'Number of post-operative days in cardiac intensive care unit (CICU) and hospital.'}, {'measure': 'Mortality', 'timeFrame': 'Duration of hospitalization, 30 days post-op, and at last follow-up'}, {'measure': 'Biomarkers for AKI', 'timeFrame': '72 hours', 'description': 'Serum and urine will be collected for biomarker discovery.'}, {'measure': 'Inflammation', 'timeFrame': '72 hours', 'description': 'Cytokines will be measured at baseline until 72 hours post-operative.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatric', 'Cardiac', 'Surgery', 'Cardiopulmonary', 'Bypass', 'Myocardial', 'Kidney', 'Lung', 'Injury'], 'conditions': ['Congenital Heart Disease', 'Cardiopulmonary Bypass', 'Myocardial Injury', 'Acute Kidney Injury', 'Acute Lung Injury']}, 'referencesModule': {'references': [{'pmid': '38172875', 'type': 'DERIVED', 'citation': 'Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.'}]}, 'descriptionModule': {'briefSummary': 'Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.', 'detailedDescription': 'In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge birth to 18 years Cardiac surgery with planned cardiopulmonary bypass\n\nExclusion Criteria:\n\nAny contraindication to compression of lower extremity/extremities Body weight \\<2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery'}, 'identificationModule': {'nctId': 'NCT01260259', 'acronym': 'SCRIPT', 'briefTitle': 'Seattle Cardiorenal Remote Ischemic Preconditioning Trial', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'CCTR-3953179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Ischemic Preconditioning (RIPC)', 'interventionNames': ['Procedure: RIPC']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'RIPC', 'type': 'PROCEDURE', 'description': 'RIPC will be elicited in the operating room (OR) after anesthesia induction and before start of surgery. After placement of an arterial line, a tourniquet will be placed over a lower extremity. It will be inflated to 15 mmHg above systolic blood pressure for 5 minutes, and then deflated for 5 minutes. This cycle of inflation-deflation will be repeated another 3 times before surgery.', 'armGroupLabels': ['Remote Ischemic Preconditioning (RIPC)']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Christine W Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital and University of Washington"}, {'name': 'Yuk Law, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital and University of Washington"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christine Hsu', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}