Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-01-04 @ 3:36 AM
Study NCT ID:
NCT05223361
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2022-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-23', 'studyFirstSubmitDate': '2022-01-08', 'studyFirstSubmitQcDate': '2022-01-23', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants required blood transfusion', 'timeFrame': 'Up to discharge, an average of 8 days', 'description': 'The volume of blood transfusion after heart valve surgery'}], 'secondaryOutcomes': [{'measure': 'Number of participants died in hospital', 'timeFrame': 'Up to discharge, an average of 8 days', 'description': 'Any cause of death after heart valve surgery'}, {'measure': 'Duration of ventilation time', 'timeFrame': 'During ICU admission, an average of 2 days', 'description': 'The duration ventilation time after heart valve surgery'}, {'measure': 'ICU length of stay', 'timeFrame': 'During ICU admission, an average of 2 days', 'description': 'The length of stay in intensive care unit'}, {'measure': 'Hospital length of stay', 'timeFrame': 'During hospital admission, an average of 8 days', 'description': 'The length of stay in hospital after heart valve surgery'}, {'measure': 'Number of participants required chest tube drainage', 'timeFrame': 'During hospital admission, an average of 8 days', 'description': 'The amount of drainage from chest tube after heart valve surgery'}, {'measure': 'Number of participants required re-operation for bleeding', 'timeFrame': 'During hospital admission, an average of 8 days', 'description': 'Re-operation due to excessive bleeding after heart valve surgery'}, {'measure': 'Number of participants died in one month', 'timeFrame': 'One month after surgery', 'description': 'Any cause of death within one month after heart valve surgery'}, {'measure': 'Changes in hemoglobin concentration', 'timeFrame': 'Up to 48 hours after heart valve surgery', 'description': 'Changes in hemoglobin after heart valve surgery'}, {'measure': 'Changes in hematocrit concentration', 'timeFrame': 'Up to 48 hours after heart valve surgery', 'description': 'Changes in hematocrit after heart valve surgery'}, {'measure': 'Changes in serum lactate concentration', 'timeFrame': 'Up to 48 hours after heart valve surgery', 'description': 'Changes in serum lactate after heart valve surgery'}, {'measure': 'Changes in serum blood sugar concentration', 'timeFrame': 'Up to 48 hours after heart valve surgery', 'description': 'Changes in serum blood sugar after heart valve surgery'}, {'measure': 'Number of participants with acute kidney injury', 'timeFrame': 'Up to 48 hours after heart valve surgery', 'description': 'The development of acute kidney injury after heart valve surgery'}, {'measure': 'Changes in liver enzyme concentration', 'timeFrame': 'Up to 48 hours after heart valve surgery', 'description': 'Changes in liver enzyme after heart valve surgery'}, {'measure': "Amount of cerebral hemispheres' oxygenation", 'timeFrame': 'During cardiopulmonary bypass time', 'description': 'The amount of cerebral oxygenation measured by INVOS in both hemispheres'}, {'measure': 'Changes in coagulation parameters', 'timeFrame': 'Up to 48 hours after heart valve surgery', 'description': 'Changes in coagulation parameters after heart valve surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Valve Diseases']}, 'descriptionModule': {'briefSummary': 'In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. The first group will receive hydroxyethyl starch (HES) 130/0.4 additive to ringer lactate (RL) and the second group will be given only RL as priming solution. All patients will be observed closely during postoperative days. Through follow up, bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be recorded in both groups.', 'detailedDescription': 'Cardiopulmonary bypass (CPB) pump is a device for circulating blood in the body while the heart is undergone surgery. For providing circulating volume in the body we need to add about 1.5 to 2 lit fluids as priming solution in the CPB pump. Some fluids mainly included crystalloids, colloids, starch, and gelatin in an only fluid or in a combined formula. During CPB time, the blood dilution is caused by adding prime solution into the circulating volume, and consequently it decreases blood viscosity. Moreover, in addition to a decrease in hematocrit level, coagulation factors and plasma proteins can dramatically decreased. These processes may lead to bleeding events and tissue hypoperfusion and organ damages. To decrease complications, some modalities such as adding colloids to crystalloids have been implemented. On the other hand, any regimen for priming solution has its shortcomings need to be considered based on patient condition and surgical issue.\n\nIn this double blinded randomized clinical trial study, we aimed to compare the the effects of six percent HES 130/0.4 and RL as priming solutions on coagulation factors, renal function, hepatic function, and cerebral oxygenation in patients undergoing open heart valve surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients who provided written informed consent and had no heart failure (LVEF \\>55%), no hepatic failure (defined as aspartate aminotransferase (AST) \\>40 mg/dL and/or alanine aminotransferase (ALT) \\>40 mg/dL), no prior history of cardiac surgery, serum creatinine \\<1.5 mg/dL, no episode of drug-induced acute kidney injury within preoperative 5 days, no severe carotid stenosis in both or one of them, no emergency valvular stenosis, no infective endocarditis, no severe right ventricular failure, no hemoglobin \\<10 mg/dL, no body mass index \\>40 kg/m2, no heparin-induced thrombocytopenia, no cancer, no severe pulmonary valve insufficiency, no pulmonary function test \\<65% before heart valve surgery\n\nExclusion Criteria:\n\nincluded consent withdrawal by the patient or by his/her proxy, allergic reaction to the drugs, the aortic cross clamp time greater than 120 minutes, on-pump time greater than 150 minutes, the performance of the retrograde autologous priming.'}, 'identificationModule': {'nctId': 'NCT05223361', 'briefTitle': 'Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rajaie Cardiovascular Medical and Research Center'}, 'officialTitle': 'Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery', 'orgStudyIdInfo': {'id': 'HVDRC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxy ethyl starch (HES)', 'description': 'Six percent hydroxy ethyl starch 130/0.4 additive to ringer lactate as priming solution during CPB', 'interventionNames': ['Drug: Six percent hydroxy ethyl starch 130/0.4', 'Drug: Ringer lactate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ringer lactate (RL)', 'description': 'Ringer lactate as priming solution during CPB', 'interventionNames': ['Drug: Ringer lactate']}], 'interventions': [{'name': 'Six percent hydroxy ethyl starch 130/0.4', 'type': 'DRUG', 'description': '6% HES 130/0.4 additive to ringer lactate as prime solution', 'armGroupLabels': ['Hydroxy ethyl starch (HES)']}, {'name': 'Ringer lactate', 'type': 'DRUG', 'description': 'Ringer lactate as prime solution', 'armGroupLabels': ['Hydroxy ethyl starch (HES)', 'Ringer lactate (RL)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Rajaie CMRC', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We will decide per request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rajaie Cardiovascular Medical and Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart Valve Disease Research Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rajaie Cardiovascular Medical and Research Center', 'investigatorFullName': 'Rajaie cardiovascular medical & research center', 'investigatorAffiliation': 'Rajaie Cardiovascular Medical and Research Center'}}}}