Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT02336620
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2015-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of hyperchloremic metabolic acidosis', 'timeFrame': '48 hour'}], 'secondaryOutcomes': [{'measure': '28 day and 90 day mortality rate', 'timeFrame': '28 days and 90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Severe sepsis, Balanced Salt Solution, Normal Saline'], 'conditions': ['Shock, Septic', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock', 'detailedDescription': 'The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized controlled trial compare efficacy between the balanced salt solution and chloride rich solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children younger than 18 year old who has severe sepsis or septic shock\n* inform consent\n\nExclusion Criteria:\n\n* children who had shock from other aetiologies\n* end stage disease or severe congenital anomaly\n* refuse to inform consent'}, 'identificationModule': {'nctId': 'NCT02336620', 'briefTitle': 'Balanced Salt Solution VS. Normal Saline Solution in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RF_58015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ringer Acetate', 'description': 'Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus', 'interventionNames': ['Drug: Ringer acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal saline', 'description': 'NSS 10-20 ml/kg IV bolus when patient need fluid bolus', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Ringer acetate', 'type': 'DRUG', 'description': 'Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status', 'armGroupLabels': ['Ringer Acetate']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['NSS'], 'description': 'NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Pediatric,Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Nattachai Anantasit, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital, Bangkok'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Department, Ramathibodi Hospital', 'investigatorFullName': 'Nattachai Anantasit', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}