Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:23 AM
Study NCT ID:
NCT07354958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2025-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Diabetes-Related Metabolic Derangements on Clinical Outcomes in Hospitalized Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2025-12-25', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-Hospital Mortality', 'timeFrame': 'From admission until hospital discharge, assessed over a 6-month study enrollment period.', 'description': 'Patient death from any cause occurring during the hospitalization period'}, {'measure': 'New Requirement for In-Hospital Renal Replacement Therapy', 'timeFrame': 'From admission until hospital discharge, assessed over a 6-month study enrollment period.', 'description': 'Initiation of dialysis in a patient who was not receiving renal replacement therapy at the time of hospital admission'}, {'measure': 'Incidence of a Major In-Hospital Cardiovascular Composite Event', 'timeFrame': 'From admission until hospital discharge, assessed over a 6-month study enrollment period.', 'description': 'A composite outcome defined as the first occurrence of any of the following during the hospitalization: myocardial infarction, stroke, or new-onset heart failure requiring inotropic support or mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Chronic Kidney Disease Patients']}, 'descriptionModule': {'briefSummary': 'This observational study will collect clinical and laboratory information from hospitalized patients with chronic kidney disease to identify diabetes mellitus and selected metabolic findings during hospitalization', 'detailedDescription': 'Hospitalized adult patients with chronic kidney disease will be included in this observational study. Information routinely recorded during hospitalization will be collected. This information will include the presence of diabetes mellitus and laboratory values related to blood glucose levels, electrolyte levels, and acid base balance. No study related interventions will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A) Inclusion criteria:\n\n* Age ≥18 years.\n* Known CKD (baseline eGFR \\<60 mL/min/1.73 m² for ≥3 months) OR documented CKD stage 3-5 by prior records.\n* Hospitalized for any medical reason.\n* Consent provided.\n\nB) Exclusion criteria:\n\n* Acute single episode of reversible AKI with previously normal renal function (no established CKD).\n* Admission for palliative care /expected survival \\<24 hours.\n* Pregnancy.\n\nC) Patient groups (for analysis):\n\nDiabetes status:\n\n* Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission).\n* Non-diabetic CKD.\n\nD) Subgroups / Diabetic patient group: Metabolic derangement categories\n\n1. Acute hyperglycemia\n\n * Diabetic ketoacidosis (DKA) /hyperosmolar hyperglycemic state (HHS)\n * Patients without DKA or HHS\n2. Hypoglycemia\n\n * Hypoglycemia: any blood glucose \\<70 mg/dL (and severe \\<40 mg/dL).\n * Without Hypoglycemia episodes\n3. Metabolic acidosis arterial or venous HCO₃- \\<20 mmol/L or pH \\<7.35 with anion gap \\>12 as appropriate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Known chronic kidney disease, defined as baseline estimated glomerular filtration rate less than 60 milliliters per minute per 1.73 square meters for at least 3 months, or documented chronic kidney disease stage 3 to 5 by prior medical records\n* Hospitalized for any medical reason\n* Consent provided\n\nExclusion Criteria:\n\n* Acute single episode of reversible acute kidney injury with previously normal renal function (no established chronic kidney disease)\n* Admission for palliative care or expected survival less than 24 hours\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07354958', 'briefTitle': 'Impact of Diabetes-Related Metabolic Derangements on Clinical Outcomes in Hospitalized Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Impact of Diabetes-Related Metabolic Derangements on Clinical Outcomes in Hospitalized Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'Soh-Med--25-12-5MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1. Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). 2. Non-diabetic CKD', 'interventionNames': ['Behavioral: Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosi']}], 'interventions': [{'name': 'Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosi', 'type': 'BEHAVIORAL', 'description': 'Primary aim\n\n1. To assess the frequency of diabetes mellitus among hospitalized CKD patients.\n2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosis/ hyperosmolar states, metabolic acidosis, dyslipidemia, electrolyte imbalance) in diabetic CKD patients.\n\nSecondary aim\n\n1\\. To evaluate the association between diabetes and diabetes-related metabolic derangements in-hospital adverse outcomes (major cardiovascular events, ICU admission, length of stay, infection rate, need for dialysis and mortality) among hospitalized patients with CKD.', 'armGroupLabels': ['1. Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). 2. Non-diabetic CKD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Mahmoud Rashad, Master Degree', 'role': 'CONTACT', 'email': 'mohammed_rashad_post@med.sohag.edu.eg', 'phone': '01153640803'}, {'name': 'Mahmoud Ibrahim Yousef, Associate Professor', 'role': 'CONTACT', 'email': 'mahmoudibrahim@med.sohag.edu.eg'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed Mahmoud Rashad, Master Degree', 'role': 'CONTACT', 'email': 'mohammed_rashad_post@med.sohag.edu.eg', 'phone': '01153640803'}, {'name': 'Mahmoud Ibrahim Yousef, Associate Professor', 'role': 'CONTACT', 'email': 'mahmoudibrahim@med.sohag.edu.eg', 'phone': '01065964083'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in Internal Medicine department at sohage university', 'investigatorFullName': 'Mohamed Mahmoud Rashad', 'investigatorAffiliation': 'Sohag University'}}}}