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Clinical Trials/NCT07338734
NCT07338734
Not yet recruiting
Not Applicable

Fluid Balance During Early Hours of Acute Kidney Injury in Critically Ill Patients

Assiut University0 sites120 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Assiut University
Enrollment
120
Primary Endpoint
Incidence of Acute Kidney Injury (AKI)

Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults aged 18 years or older admitted to the ICU.
  • Patients with no AKI at ICU admission.
  • 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

Exclusion Criteria

  • Patients with pre-existing end-stage renal disease requiring dialysis.
  • Patients with known chronic kidney disease stage 4 or higher.
  • ICU readmissions during the same hospitalization.
  • Patients who received renal replacement therapy before ICU admission
  • Patients with AKI with manifestation of over load as pulmonary edema- pulmonary embolism-Acute decompensated heart failure

Outcomes

Primary Outcomes

Incidence of Acute Kidney Injury (AKI)

Time Frame: Within 7 days after ICU admission

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).

Secondary Outcomes

  • AKI Stage by KDIGO Criteria(Within 7 days after ICU admission)

Investigators

Sponsor
Assiut University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Engy Bassam Gayel Sayed

Resident at Internal Medicine Department, Assiut University

Assiut University

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