Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-26 @ 9:51 PM
Study NCT ID:
NCT02445820
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2015-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HES and Acute Kidney Injury in Adult Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'C048013', 'term': 'Plasmalyte A'}], 'ancestors': [{'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 697}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2015-05-05', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AKIN SCr', 'timeFrame': 'Forty eight hours', 'description': 'Stage of acute kidney injury using the Acute Kidney Injury Network Classification omitting the diuresis criteria.'}], 'secondaryOutcomes': [{'measure': 'AKIN SCr+UO', 'timeFrame': 'Forty eight hours', 'description': 'Stage of acute kidney injury using the Acute Kidney Injury Network Classification including the diuresis criteria.'}, {'measure': 'Postoperative dialysis', 'timeFrame': '30 days', 'description': 'Requirement of postoperative renal replacement therapy'}, {'measure': 'Respiratory complication', 'timeFrame': '30 days', 'description': 'Need for reintubation, non-invasive ventilation or prolonged intensive care unit stay as a consequence of atelectasis, pulmonary edema or pneumonia.'}, {'measure': 'ICU stay', 'timeFrame': '30 days', 'description': 'Length of stay at the intensive care unit'}, {'measure': 'Hospital stay', 'timeFrame': '30 days', 'description': 'Length of stay at the hospital'}, {'measure': '30-day mortality', 'timeFrame': '30 days', 'description': 'Death in hospital or within 30 days of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury After Adult Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults patients undergoing cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 yo\n* Having on pump cardiac surgery at CHU of Liège between April 2013 and June 2014\n\nExclusion Criteria:\n\n* Off pump surgery\n* Use of Blood or Albumin in the cardiopulmonary bypass priming solution\n* Preoperative dialysis'}, 'identificationModule': {'nctId': 'NCT02445820', 'briefTitle': 'HES and Acute Kidney Injury in Adult Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'The Association Between Hydroxyethyl Starch 130/0.4 and Acute Kidney Injury After Cardiopulmonary Bypass: a Single-center Retrospective Study', 'orgStudyIdInfo': {'id': 'ANES2015002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HES', 'description': 'Balanced HES 130/0.4 used as and pump prime and for intraoperative fluid therapy.', 'interventionNames': ['Drug: HES']}, {'label': 'Crystalloid', 'description': 'Balanced Crystalloid used as a pump prime and for intraoperative fluid therapy.', 'interventionNames': ['Drug: Crystalloid']}], 'interventions': [{'name': 'HES', 'type': 'DRUG', 'otherNames': ['Volulyte®'], 'description': '2500 mL of balanced HES 130/0.4', 'armGroupLabels': ['HES']}, {'name': 'Crystalloid', 'type': 'DRUG', 'otherNames': ['Plasmalyte A ®'], 'description': '2500 mL of balanced crystalloid.', 'armGroupLabels': ['Crystalloid']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia and Intensive Care Medicine', 'investigatorFullName': 'Jean François Brichant', 'investigatorAffiliation': 'University of Liege'}}}}