Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT06651892
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2024-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in The Treatment of Hypophosphatemia in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2024-05-12', 'studyFirstSubmitQcDate': '2024-10-19', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy in replacing phosphate', 'timeFrame': '2 days', 'description': 'percentage of patients achieving a normal (\\>/=2.5mg/dl) or increase in serum level of phosphate'}], 'secondaryOutcomes': [{'measure': 'occurrence of potential side effects', 'timeFrame': '2 days', 'description': 'Monitoring of Clinical complications of phosphate replacement like diarrhea, measured as Number of events (watery diarrhea) \\> 3 times/day, and New Onset of Hypocalcemia /Hypercalcemia or Hypernatremia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Hypophosphatemia']}, 'referencesModule': {'references': [{'pmid': '41242387', 'type': 'DERIVED', 'citation': 'Najdi H, Sayed R, Mettawi AS, El-Hamamsy M. The efficacy and safety of diluted oral phosphate enema versus intravenous sodium glycerophosphate in the treatment of hypophosphatemia in intensive care unit patients - A non-inferiority trial. Clin Nutr ESPEN. 2025 Dec;70:692-700. doi: 10.1016/j.clnesp.2025.11.015. Epub 2025 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to study the efficacy and safety of diluted phosphate enema in treating hypophosphatemia in adults in critical care unit in comparison to intravenous sodium glycero-phosphate as the current standard of care.\n\nThe main question it aims to answer is:\n\ncan the investigators rely on phosphate enemas as an effective and safe treatment option for hypophosphatemia in critically ill adults, in the era of global shortage of parenteral nutrition solutions and the absence of defined guidelines for treatment of acute hypophosphatemia in those population.', 'detailedDescription': 'A Randomized Controlled Trial - Non inferiority trial of 2 groups, Eligible participants will be randomly assigned to one of two groups (Intervention Group will receive Diluted Oral phosphate enema as the repletion strategy, while Control Group will receive The Standard of care: intravenous sodium glycerophosphate) for the purpose of treatment of hypophosphatemia in critically ill patients.\n\nDose Calculation: as per hospital protocol and scientific reference(Crook, 2009) 0.32 mmol per kg for mild hypophosphatemia 0.64 mmol per kg for moderate hypophosphatemia\n\nAll participants will be reassessed the next day after the intervention and followed up for the occurrence of any side effects, then participants will be followed up again the day after. (Assessment of serum phosphate and sodium along with occurrence of diarrhea or any other side effects).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill Patients with mild (2-2.4 mg/dl) to moderate (1.5-1.9 mg/dl) hypophosphatemia.\n* Serum phosphorus level less than 2.5mg/dl - between 1.5 - 2.5mg/dl\n* Patients 18 years or older\n\nExclusion Criteria:\n\n* Severe hypophosphatemia\n* Serum Phosphorus level less than 1.5 mg/dL\n* Patients on Non-peroral status\n* Ileus (as paralytic ileus, post-operative)\n* Any problem in gut integrity as (intestinal obstruction, Severe Malabsorption, severe diarrhea)\n* Any form of ischemic gut (as mesenteric ischemia, mesenteric gastric occlusion, arterial venous insufficiency)\n* Hemodynamically unstable patients\n* Severe Hypocalcemia or Hypercalcemia at the beginning of the study (when iv phosphate is deemed inappropriate at the discretion of attending physician)'}, 'identificationModule': {'nctId': 'NCT06651892', 'briefTitle': 'The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in The Treatment of Hypophosphatemia in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in The Treatment of Hypophosphatemia in ICU Patients', 'orgStudyIdInfo': {'id': 'REC #270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - oral diluted phosphate enema', 'description': 'oral diluted phosphate enema', 'interventionNames': ['Drug: Enema Phosphates Sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B - intravenous sodium glycerophosphate', 'description': 'intravenous sodium glycerophosphate', 'interventionNames': ['Drug: Glycophos Injectable Product']}], 'interventions': [{'name': 'Enema Phosphates Sodium', 'type': 'DRUG', 'otherNames': ['oral diluted phosphate enema'], 'description': 'oral diluted phosphate enema containing as a repletion strategy to replace phosphate in critically ill patients with acute hypophosphatemia.', 'armGroupLabels': ['Group A - oral diluted phosphate enema']}, {'name': 'Glycophos Injectable Product', 'type': 'DRUG', 'otherNames': ['intravenous sodium glycerophosphate'], 'description': 'intravenous sodium glycerophosphate as the standard of care or active control', 'armGroupLabels': ['Group B - intravenous sodium glycerophosphate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Al haram Hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}