Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-30 @ 7:28 PM
Study NCT ID:
NCT01428050
Status:
UNKNOWN
Last Update Posted:
2015-03-18
First Post:
2011-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-02-08', 'releaseDate': '2022-01-20'}], 'estimatedResultsFirstSubmitDate': '2022-01-20'}}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2011-08-31', 'studyFirstSubmitQcDate': '2011-09-01', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic Leak', 'timeFrame': '30 days', 'description': 'Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy'}, {'measure': 'Delayed Gastric Emptying', 'timeFrame': '30 days', 'description': 'Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding'}, {'measure': 'Myocardial Infarction', 'timeFrame': '30 days'}, {'measure': 'Pneumonia', 'timeFrame': '30 days'}, {'measure': 'Wound Infection', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['whipple', 'hypertonic saline', 'pancreaticoduodenectomy', 'fluid restriction', 'resuscitation strategy'], 'conditions': ['Pancreaticoduodenectomy']}, 'referencesModule': {'references': [{'pmid': '25115420', 'type': 'DERIVED', 'citation': 'Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.'}]}, 'descriptionModule': {'briefSummary': 'The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. The Whipple operation is associated with a significant complication rate. Previous studies have shown that in a broad range of surgical procedures, using a reduced amount of intravenous fluids along with a special type of fluid called hypertonic saline during and after the procedure can lower complication rates associated with the heart and lungs during recovery from surgery. The purpose of this study is to determine if using a reduced amount of intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous fluids) during the Whipple operation and in the immediate period after surgery can reduce complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physiologic suitability for major abdominal surgery\n* Aged 18 years and older\n* Written informed consent\n* Ability to understand and comply with study guidelines\n* Ability to obtain a central venous line\n\nExclusion Criteria:\n\n* Metabolic acidosis\n* Active Sepsis or Bacteremia\n* Chronic renal insufficiency\n* Hyponatremia (serum sodium \\<130)\n* Hypernatremia (serum sodium \\>150)\n* Pregnancy\n* Sickle cell anemia\n* Pediatric patients\n* BMI\\>40'}, 'identificationModule': {'nctId': 'NCT01428050', 'briefTitle': 'The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': 'Jefferson Hypertonic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3% saline', 'description': 'Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration', 'interventionNames': ['Drug: 3% NaCl Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lactated Ringers', 'description': '15cc/kg/hr of lactated ringers solution intraoperatively', 'interventionNames': ['Drug: Lactated Ringers Solution']}], 'interventions': [{'name': '3% NaCl Solution', 'type': 'DRUG', 'description': '1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution', 'armGroupLabels': ['3% saline']}, {'name': 'Lactated Ringers Solution', 'type': 'DRUG', 'description': '15cc/kg/hr for intraoperative fluids', 'armGroupLabels': ['Lactated Ringers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Harish Lavu, MD', 'role': 'CONTACT', 'email': 'Harish.Lavu@jeffersonhospital.org', 'phone': '215-955-9402'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Harish Lavu, MD', 'role': 'CONTACT', 'email': 'harish.lavu@jeffersonhospital.org', 'phone': '215-955-9402'}], 'overallOfficials': [{'name': 'Harish Lavu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-01-20', 'type': 'RELEASE'}, {'date': '2022-02-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Thomas Jefferson University'}}}}