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临床试验/NCT07338734
NCT07338734尚未招募不适用

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

Assiut University0 个研究点目标入组 120 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Incidence of Acute Kidney Injury (AKI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Incidence of Acute Kidney Injury (AKI)

时间窗: 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).

次要结局

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

研究者

发起方
Assiut University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Engy Bassam Gayel Sayed

Resident at Internal Medicine Department, Assiut University

Assiut University

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