Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-05-29 @ 10:16 PM
Study NCT ID:
NCT03115060
Status:
UNKNOWN
Last Update Posted:
2017-05-15
First Post:
2017-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluid During Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'C048013', 'term': 'Plasmalyte A'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient', 'timeFrame': 'during the surgery', 'description': 'pH, pCO2, pO2, HCO3,Base deficit, Na, K are the values normally measured in acid base analysis'}], 'secondaryOutcomes': [{'measure': 'serum creatinine on day 1, 2 and 7 of surgery', 'timeFrame': 'day 1, 2 and 7', 'description': 'This is a function of kidney measure and will tell about the success of Renal Transplant'}, {'measure': 'intraoperative hemodynamics in all patients', 'timeFrame': 'intraoperatively'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acid-Base Balance Disorder']}, 'descriptionModule': {'briefSummary': 'Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids. Plasmalyte is another fluid which can be used and probably will lead to better metabolic profile in these group of patients.The primary objective of this study will be to compare the effects of using normal saline (NS), Ringer lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective living donor renal transplant\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03115060', 'briefTitle': 'Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluid During Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluids in Patients Undergoing Renal Transplantation.', 'orgStudyIdInfo': {'id': 'INT/IEC/2016/937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'normal saline', 'description': 'Intravenous fluid used in these patients would be normal saline which would be given intravenously during intraoperative and postoperative period', 'interventionNames': ['Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE']}, {'type': 'EXPERIMENTAL', 'label': 'ringer lactate', 'description': 'Intravenous fluid used in these patients would be ringer lactate which would be given intravenously during intraoperative and postoperative period', 'interventionNames': ['Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE']}, {'type': 'EXPERIMENTAL', 'label': 'plasmalyte A', 'description': 'Intravenous fluid used in this arm in patients would be plasmalyte A which would be given intravenously during intraoperative and postoperative period', 'interventionNames': ['Drug: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE']}], 'interventions': [{'name': 'intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE', 'type': 'DRUG', 'description': 'intravenous fluid to be used for maintainance and replacement during renal transplant surgery will be normal saline, ringer lactate or plasmalyte A depending on the arm of intervention', 'armGroupLabels': ['normal saline', 'plasmalyte A', 'ringer lactate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'vikas saini', 'role': 'CONTACT', 'email': 'drvsaini@gmail.com', 'phone': '7087008119'}], 'facility': 'PGIMER', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Tanvir samra, MD Anaesthesia', 'role': 'CONTACT', 'email': 'drtanvirsamra@yahoo.co.in', 'phone': '7087008799'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr Vikas Saini', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}