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:
Assiut University
Organization:
Study Overview
Official Title:
Fluid Balance During Early Hours of Acute Kidney Injury in Critically Ill Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: