Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-05 @ 3:21 PM
Study NCT ID:
NCT02721095
Status:
UNKNOWN
Last Update Posted:
2016-05-03
First Post:
2015-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007008', 'term': 'Hypokalemia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-01', 'studyFirstSubmitDate': '2015-05-25', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with normal serum K as assessed by serum electrolyte', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypokalemia']}, 'descriptionModule': {'briefSummary': 'evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia', 'detailedDescription': 'Hypokalemia is frequently encountered in hospitalized patients. Intravenous (IV) potassium repletion with saline is preferred used for initial therapy. However, administration of normal saline (0.9%NaCl) usually provokes sodium and potassium diuresis, thus, it might delay reversal of the hypokalemia.\n\nObject of this study : to evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serum K+ 2.5-3.49 mmol/L\n* No life threatening condition from hypokalemia\n\nExclusion Criteria:\n\n* Pregnancy\n* Volume overload, heart failure\n* Hypotension\n* Acute kidney injury\n* Dysnatremia\n* K+ shift\n* Salt wasting nephropathy'}, 'identificationModule': {'nctId': 'NCT02721095', 'briefTitle': 'Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl', 'organization': {'class': 'OTHER', 'fullName': 'Phramongkutklao College of Medicine and Hospital'}, 'officialTitle': 'Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients', 'orgStudyIdInfo': {'id': 'PMK1981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.9%NaCl', 'description': 'KCl plus 0.9%NaCl', 'interventionNames': ['Other: KCl plus 0.9%NaCl']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.45%NaCl', 'description': 'KCl plus 0.45%NaCl', 'interventionNames': ['Other: KCl plus 0.45%NaCl']}], 'interventions': [{'name': 'KCl plus 0.9%NaCl', 'type': 'OTHER', 'description': 'comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia', 'armGroupLabels': ['0.9%NaCl']}, {'name': 'KCl plus 0.45%NaCl', 'type': 'OTHER', 'description': 'comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia', 'armGroupLabels': ['0.45%NaCl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Theerasak Tangwonglert, MD.', 'role': 'CONTACT', 'email': 'theerasak.pmk@gmail.com', 'phone': '0897750222'}, {'name': 'Theerasak - Tangwonglert, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Phramonkutklao Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Theerasak Tangwonglert, MD.', 'role': 'CONTACT', 'email': 'theerasak.pmk@gmail.com', 'phone': '0897750222'}], 'overallOfficials': [{'name': 'Yaowana Thanapat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituitional review board royal thai army medical department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phramongkutklao College of Medicine and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}