Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:47 PM
Study NCT ID:
NCT07338734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2026-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Balance in Acute Kidney Injury in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-04', 'studyFirstSubmitDate': '2026-01-04', 'studyFirstSubmitQcDate': '2026-01-04', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Acute Kidney Injury (AKI)', 'timeFrame': 'Within 7 days after ICU admission', 'description': 'Development of AKI defined by KDIGO criteria (increase in serum creatinine by ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days, or urine output \\<0.5 mL/kg/h for 6 hours).'}], 'secondaryOutcomes': [{'measure': 'AKI Stage by KDIGO Criteria', 'timeFrame': 'Within 7 days after ICU admission', 'description': 'Worst stage of AKI (Stage 1: SCr 1.5-2.9x baseline or UO \\<0.5 mL/kg/h ≥6h; Stage 2: SCr 3-5.9x or UO \\<0.5 mL/kg/h ≥12h; Stage 3: SCr ≥6x or ≥4.0 mg/dL or RIFLE F/ESRD, UO \\<0.3 mL/kg/h ≥24h or anuria ≥12h).'}]}, 'conditionsModule': {'keywords': ['Fluid Balance', 'acute kidney injury', 'AKI', 'critically ill', 'KDIGO criteria'], 'conditions': ['Fluid Balance', 'Acute Kidney Injury', 'Critically Ill Acute Kidney Injury', 'Critically Ill']}, 'descriptionModule': {'briefSummary': 'This prospective observational cohort study evaluates if fluid balance in the first 48 hours of ICU admission is linked to acute kidney injury (AKI) in critically ill adults. Patients without AKI at entry will have fluids tracked hourly via charts, weights, and labs to assess AKI risk by KDIGO criteria within 7 days. Findings may guide better fluid management to lower AKI rates.', 'detailedDescription': 'This prospective observational cohort study at Assiut University Hospital ICU investigates the association between fluid balance in the first 48 hours of admission and acute kidney injury (AKI) development. Critically ill adults (≥18 years) without AKI at baseline will undergo routine monitoring: hourly fluid intake/output (IV fluids, blood products, urine, drains, insensible losses), daily weights, serial labs (SCr, BUN, electrolytes, albumin, CRP), and clinical/hemodynamic assessments. AKI is defined/staged by KDIGO criteria within 7 days. Sample size is 120 (Epi-Info calculated, 38.4% expected AKI incidence). Data analysis will examine if positive/negative balances predict AKI incidence, severity, RRT need, ICU stay, and 28-day mortality, using AKI-FB risk score. No interventions; standard care only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18 years or older admitted to the intensive care unit (ICU) at Assiut University Hospital without acute kidney injury (AKI) at admission. Eligible cases include prerenal, renal, postrenal AKI with hypovolemia; postoperative; CKD up to stage IIIb; compensated heart failure needing fluids.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older admitted to the ICU.\n* Patients with no AKI at ICU admission.\n* AKI secondary to (prerenal cause-renal and post renal with manifestation of hypovolemia)-postoperative settings-On top of CKD up to Stage 111b-Compansated heart failure with indication of fluid therapy\n\nExclusion Criteria:\n\n* Patients with pre-existing end-stage renal disease requiring dialysis.\n* Patients with known chronic kidney disease stage 4 or higher.\n* ICU readmissions during the same hospitalization.\n* Patients who received renal replacement therapy before ICU admission\n* Patients with AKI with manifestation of over load as pulmonary edema- pulmonary embolism-Acute decompensated heart failure'}, 'identificationModule': {'nctId': 'NCT07338734', 'briefTitle': 'Fluid Balance in Acute Kidney Injury in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Fluid Balance During Early Hours of Acute Kidney Injury in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'Fluid Balance in AKI'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Internal Medicine Department, Assiut University', 'investigatorFullName': 'Engy Bassam Gayel Sayed', 'investigatorAffiliation': 'Assiut University'}}}}