Evaluation of the Effectiveness of Oral Hydration Compared to Intravenous Hydration in Preventing Contrast-Associated Acute Kidney Injury in the Emergency Department : A Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI)
研究概览
简要总结
This study is planned to be conducted by emergency physicians between November 7, 2025, and December 7, 2026.
Inclusion and Exclusion Criteria The study will include adult patients aged 18 years and older who are considered at risk for Contrast-Associated Acute Kidney Injury (CA-AKI), with an estimated Glomerular Filtration Rate (eGFR) between 15-59 ml/min/1.73 m², a clinical indication for contrast-enhanced CT, and who have provided signed informed consent.
Exclusion criteria are as follows:
Pregnant women.
Patients with a known contrast media allergy.
Contrast media exposure within the last 72 hours.
End-stage renal disease (ESRD) with eGFR <15 ml/min/1.73 m² or those receiving dialysis.
Patients with clinical decompensated heart failure.
Patients for whom oral intake is contraindicated or not tolerated.
Randomization and Interventions Prior to randomization, the oral intake capacity of eligible patients will be verified. Participants will be randomized into two groups-IV hydration and oral hydration-at a 1:1 ratio using stratified block randomization based on age and gender.
IV Hydration Group: Isotonic 0.9% NaCl solution will be administered. The regimen consists of 3 ml/kg for 1 hour pre-procedure, followed by 2 ml/kg/hour for 4 hours post-procedure. Patients with an ejection fraction (EF) <40% will receive half-doses (1.5 ml/kg pre-procedure; 1 ml/kg/hour for 4 hours post-procedure).
Oral Hydration Group: Drinking water will be administered under nursing supervision. The regimen consists of 500 ml 1 hour pre-procedure and 125 ml/hour for 4 hours post-procedure. Patients with an EF <40% will receive half-doses (250 ml pre-procedure; 62.5 ml/hour post-procedure).
Follow-up and Outcome Measures Baseline renal function tests will be obtained from all patients prior to the protocol. Patients will be re-evaluated for CA-AKI via blood samples taken 48-72 hours after contrast administration.
Furthermore, eGFR changes will be calculated using the Modification of Diet in Renal Disease (MDRD) formula. Mehran Risk Scores will also be determined for each patient. Long-term outcomes, including progression to ESRD (requirement for dialysis) and mortality within 1 month, as well as creatinine levels between days 30-45, will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Patients with an estimated Glomerular Filtration Rate (eGFR) between 15-59 mL/min/1.73 m².
- •Patients undergoing contrast-enhanced computed tomography (CT) in the emergency department.
- •Patients who have provided written informed consent.
排除标准
- •Pregnant women.
- •Patients with end-stage renal disease (ESRD) receiving dialysis or those with an eGFR <15 mL/min/1.73 m².
- •Patients presenting with decompensated heart failure.
- •Patients with a known allergy to iodinated contrast media.
- •Patients with contrast media exposure within the last 72 hours.
- •Patients for whom oral intake is contraindicated or who cannot tolerate oral intake
研究组 & 干预措施
Oral Hydration Therapy
Participants in the oral hydration group will receive 500 mL of drinking water 1 hour before the contrast-enhanced CT procedure. Following the procedure, they will receive 125 mL/hour of water for a total of 4 hours under nursing supervision. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 250 mL before the procedure and 62.5 mL/hour for 4 hours post-procedure.
干预措施: Water (Dietary Supplement)
IV Hydration Therapy
Participants in the intravenous (IV) hydration group will receive isotonic 0.9% NaCl solution. The protocol consists of 3 mL/kg for 1 hour before the procedure, followed by 2 mL/kg/hour for 4 hours post-procedure. For patients with an ejection fraction (EF) <40%, the hydration dose is halved: 1.5 mL/kg before the procedure and 1 mL/kg/hour for 4 hours post-procedure.
干预措施: %0,9 NaCl (Other)
结局指标
主要结局
Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI)
时间窗: 48 to 72 hours after contrast media administration
The percentage of participants who develop CA-AKI, defined by the ESUR 10.0 (2018) criteria as an absolute increase in serum creatinine of at least 0.3 mg/dL or a relative increase of at least 50% from the baseline value within 48-72 hours after contrast media administration.
次要结局
- New-Onset Dialysis Requirement or Mortality(Within 30-45 days post-procedure)