Fluid Balance in Acute Kidney Injury in Critically Ill Patients

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.

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Key information

Conditions

Fluid Balance Acute Kidney Injury Critical Illness Critically Ill Critically Ill Acute Kidney Injury Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: Within 7 days after ICU admission

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).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 14, 2026
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed