Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT06097104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-08-05
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrolytes Disturbances in Critically Ill Egyptian Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-08', 'releaseDate': '2024-08-31'}], 'estimatedResultsFirstSubmitDate': '2024-08-31'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-26', 'size': 499515, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-16T17:25', 'hasProtocol': True}, {'date': '2023-09-26', 'size': 425895, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-16T17:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-08-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impact of electrolytes imbalances for general health status', 'timeFrame': '1 year', 'description': 'Laboratory: levels of serum sodium "mmol/L", potassium "mmol/L", magnesium "mg/dl", phosphorus "mg/dl", ionized calcium "mmol/L" and chloride "mmol/L", with maximum 5 mm blood sampling per day. Serum-sodium levels will be corrected for serum-glucose by lowering the sodium concentration by 2.4 mmol/L for every 100 mg/dl increase in glucose.\n\nCorrected Sodium = Measured sodium + 0.016 (Serum glucose - 100). A correction formula was also used to calculate albumin-corrected calcium levels (mmol/L).\n\nCorrected Calcium = (0.8 (Normal Albumin - Pt\'s Albumin)) + Serum Ca'}], 'secondaryOutcomes': [{'measure': 'impact of electrolytes imbalances for hospital stay', 'timeFrame': '1 year', 'description': 'calculation of hospital admission days and correlations with records of serum electrolytes results per admission'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrolytes', 'Egyptian'], 'conditions': ['Electrolyte Imbalance']}, 'descriptionModule': {'briefSummary': 'All selected individuals will be subjected to the following:\n\n1. Full medical history taking\n2. Full clinical examination, APACHE II score on admission\n3. Electrolytes panel daily on ICU admission\n4. Estimate the duration of stay at ICU Also all selected individuals will be sectioned into groups regarding sites of collection (surgical ICU, CCU and medical ICU). All collected individuals will be sectioned regarding electrolytes imbalance into mild, moderate and severe groups', 'detailedDescription': 'Study Procedures: All selected individuals will be suffering from electrolyte imbalance (EI) with the following data will be obtained:\n\no Measurements:\n\n1. Demographic data: age - gender - BMI - electrolytes data on ICU admission\n2. Vital data: heart rate - respiratory rate - blood pressure measurement - Oxygen saturation - Urinary output - Temp +/- CVP measurement.\n3. Lab.: "CBC - Kidney function tests - liver function tests - ABG - levels of serum sodium, potassium, magnesium, phosphorus, ionized calcium and chloride", with maximum 5 mm blood sampling per day. Serum-sodium levels will be corrected for serum-glucose by lowering the sodium concentration by 2.4 mmol/L for every 100 mg/dl increase in glucose. Corrected Sodium = Measured sodium + 0.016 (Serum glucose - 100) A correction formula was also used to calculate albumin-corrected calcium levels (mmol/L) Corrected Calcium = (0.8 (Normal Albumin - Pt\'s Albumin)) + Serum Ca\n4. APACHE II score\n5. Comorbidities\n6. Complications: AKI- Acute myocardial infarction\n7. Duration of ICU stay\n8. Duration of hospital stay\n9. Outcome (regarding eventual complications: AKI- Acute myocardial infarction)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'critically ill Egyptian patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All patients admitted to medical ICU, surgical ICU and CCU suffering from electrolyte imbalance (EI) over 18 years with the comorbid conditions :\n\n1. Hypertension\n2. Heart failure\n3. Chronic chest diseases\n4. Cancers\n5. Chronic kidney disease\n6. Diabetes mellitus\n7. Cardiac dysrhythmias\n8. Pneumonia\n9. Sepsis\n10. Dehydration\n11. Critical bones fractures\n\nExclusion Criteria:\n\n* Patients with\n\n 1. Age less than 18 year old\n 2. Patient or his 1st degree relatives refuse to participate\n 3. Patients without electrolytes data\n 4. Current smoking'}, 'identificationModule': {'nctId': 'NCT06097104', 'briefTitle': 'Electrolytes Disturbances in Critically Ill Egyptian Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Incidence, Risk Factors and Outcomes of Electrolytes Disturbances in Critically Ill Egyptian Patients: A Single-Centre Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'FMASU MD195/2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'electrolytes - serum blood samples', 'type': 'OTHER', 'description': 'CBC - Kidney function tests - liver function tests - ABG - levels of serum sodium, potassium, magnesium, phosphorus, ionized calcium and chloride", with maximum 5 mm blood sampling per day'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7154411', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Michael Sadek, MD candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-31', 'type': 'RELEASE'}, {'date': '2024-11-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ain Shams University'}}}}