Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
Study NCT ID:
NCT03553394
Status:
TERMINATED
Last Update Posted:
2022-10-10
First Post:
2018-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028570', 'term': "Ringer's acetate"}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to either receive a fluid bolus immediately when urinary output is decreased for two consecutive hours or to await fluid bolus therapy for two more hours.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'whyStopped': 'Stopped after interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary output', 'timeFrame': '2 hours', 'description': 'Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..'}], 'secondaryOutcomes': [{'measure': 'Renal function', 'timeFrame': '48 hours', 'description': 'Renal function after 48 hours'}, {'measure': 'Cumulative fluid balance', 'timeFrame': '48 hours', 'description': 'Difference in cumulative fluid balance'}, {'measure': 'Postoperative complications', 'timeFrame': '90 days', 'description': 'Frequency of postoperative complications in both groups'}, {'measure': 'Renal replacement therapy', 'timeFrame': 'Up to 90 days', 'description': 'The need for renal replacement therapy during the hospital stay'}, {'measure': 'Mortality', 'timeFrame': '90 days', 'description': '90-day mortality in both groups'}, {'measure': 'Inotropy', 'timeFrame': '1 week', 'description': 'Postoperative need of inotropic therapy during the stay in the postoperative department'}, {'measure': 'Vasopressin (ADH)', 'timeFrame': '1 day', 'description': 'Levels of vasopressin in serum immediately before and after the operation'}, {'measure': 'S-osmolality', 'timeFrame': '1 day', 'description': 'S-osmolality immediately before and after the operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fluid Therapy', 'Postoperative Period', 'Postoperative Complications', 'Pancreas Disease', 'Fluid Overload']}, 'descriptionModule': {'briefSummary': 'Reduced urinary output is a common postoperative issue for patients going through major surgery such as pancreatic surgery. Commonly this is treated by increasing fluid administration to the patients and sometimes also diuretics. However, overloading patients with fluid also have several risks and known complications. Studies have also shown that a short period of decreased urinary output in the postoperative period do not have an increased incidence of acute renal failure. The aim of our study is to investigate the difference in renal function and postoperative complications associated with fluid overload on these patients that are randomized to either receiving a fluid bolus directly when urinary output decreases or to await for a maximum of four hours to see if urinary output increases spontaneously.', 'detailedDescription': "Patents after pancreatic surgery will be included in the study. Oliguric patients (urine output \\<0.5 ml/kg/h) will be randomized to fluid bolus (5ml/kg Ringer's Acetate in 30 minutes) or no intervention. Primary outcome is difference in urine output two hours after the fluid bolus or no intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients going through pancreatic surgery.\n\nExclusion Criteria:\n\n* If not oliguric (urinary output \\<0,5 mls/kg/h) during their stay in the postoperative department\n* Hemodynamic instability (the need for \\>0,1 microgram/kg/min of norepinephrine to keep an acceptable mean arterial pressure based on the patients starting mean arterial pressure).\n* Patients that do not want to be a part of the study.\n* \\<18 years old'}, 'identificationModule': {'nctId': 'NCT03553394', 'briefTitle': 'Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'The Effects on Fluid Balance and Renal Function Using a Restrictive Fluid Strategy in the Postoperative Setting in Patients With Low Urinary Output Undergoing Pancreatic Surgery', 'orgStudyIdInfo': {'id': '2018/147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care group', 'description': "Will receive a fluid bolus 5 ml/kg Ringer's Acetate infusion immediately if oliguric/anuric for two consecutive hours (standard of care).", 'interventionNames': ["Drug: Ringer's Acetate"]}, {'type': 'NO_INTERVENTION', 'label': 'Expectant management group', 'description': 'Await fluid therapy for 2 hours. Will NOT receive a fluid bolus if oliguric/anuric for two consecutive hours and a now assessment will be made after two more hours.'}], 'interventions': [{'name': "Ringer's Acetate", 'type': 'DRUG', 'otherNames': ['Ringer Acetate'], 'description': "Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours", 'armGroupLabels': ['Standard of care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Central ICU (CIVA), Uppsal university hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Miklos Lipcsey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}