Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT03741257
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2018-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2018-11-11', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total volume of infused fluids', 'timeFrame': '24 hours', 'description': 'the total volume of fluids given to subjects intraoperatively and postoperatively'}], 'secondaryOutcomes': [{'measure': 'surgical complications rate', 'timeFrame': '4 days', 'description': 'the rate of surgical complications i.e leakage and wound dehisence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Obstruction Fluid Management With Hypertonic Saline']}, 'descriptionModule': {'briefSummary': "Background and Rationale :\n\nPerioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. Recently hypertonic saline (HS) has the advantage of using the patient's own total body water by drawing interstitial space. Although it still controversial whether HS is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation.\n\nObjectives :\n\n* Measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and S.lactate\n* The incidence rate of surgical complications; infection and anastomotic dehiscence\n\nStudy population \\& Sample size :\n\nThere were no previous trials comparing the two studied groups of the current trial. We expected a small standardized effect size of 0.2. Based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (Whitehead et al; 2016)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-70 years old\n* ASA≤III\n* BMI 25-40kg/m.\n\nExclusion Criteria:\n\n* Severe CVS diseases (EF\\<50%)\n* Severe pulmonary diseases (Pulmonary function test ≤ 50% of predicted)\n* Neurological disorders; Psychological diseases, demyelinating lesions, Parkinsonism, motor or sensory disorders.\n* Pregnancy.\n* Severe chronic renal disease (s. Creatinine\\> 2gm/dl or patients on dialysis).\n* Severe hepatic impairment (Child \\& Pugh classification class C).\n* Acid-base and electrolytes disturbances.'}, 'identificationModule': {'nctId': 'NCT03741257', 'briefTitle': 'Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery', 'orgStudyIdInfo': {'id': 'N-55-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Received Hypertonic saline 3% as resuscitation fluid.', 'interventionNames': ['Drug: Hypertonic saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Received Hypertonic saline 1.8% as resuscitation', 'interventionNames': ['Drug: Hypertonic saline']}], 'interventions': [{'name': 'Hypertonic saline', 'type': 'DRUG', 'description': 'resuscitation fluid', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Lotfy, MD', 'role': 'CONTACT', 'email': 'ahmed.lotfy@kasralainy.edu.eg', 'phone': '+201000608905'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Rasha Behery, MD', 'role': 'CONTACT', 'email': 'rasha.behery.rz@gmail.com', 'phone': '+201228604556'}, {'name': 'Ahmed Lotfy, MD', 'role': 'CONTACT', 'email': 'ahmed.lotfy@kasralainy.edu.eg', 'phone': '+201000608905'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia and intensive care', 'investigatorFullName': 'Ahmed Mohamed Lotfy', 'investigatorAffiliation': 'Cairo University'}}}}