Comparison of Bolus and Continuous Hydration Regimens for the Prevention of Contrast-Associated Acute Kidney Injury in the Emergency Department: A Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Rate of Participants Who Developed Contrast-Associated Acute Kidney Injury (CA-AKI)
研究概览
简要总结
A single-center, prospective, open-label, non-inferiority randomized controlled clinical trial was conducted at the ED of a tertiary hospital. The ED staff consisted of a mix of emergency medicine specialists, emergency medicine residents, and general practitioners.
Between August 10, 2024, and March 26, 2025, patients aged 18 and over who presented to the ED with creatinine levels above the reference range (1.2 mg/dl in men and 1.1 mg/dl in women) and underwent contrast-enhanced tomography were deemed eligible for inclusion in the study.
Eligible patients were randomly allocated in a 1:1 ratio to receive either bolus hydration or continuous hydration therapy. Permuted block randomization was employed at each participating site to distribute patients, stratified by age groups (18-44, 45-59, 60-74, and 75 years and older) and gender. This study did not use blinding. Both the implementers of the intervention and the researchers evaluating the outcome measures are aware of the intervention groups.
After the patients were divided into two groups, one group received bolus hydration therapy while the other group received continuous hydration therapy.
According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol.
The IV contrast agent used in the study was iohexol, which belongs to the non-ionic low osmolar contrast agent group. 300 mgI/ml 100 ml solutions were used, and the dose was adjusted between 80 and 100 ml depending on the imaging and the patient. In the majority of patients, 100 ml of contrast was administered, with an average of 98 ml of solution given in the bolus hydration group and an average of 96 ml of solution given in the continuous hydration group.
Patients were given control forms to provide follow-up blood samples 48-72 hours later and were asked to present to the ED with the form on the specified date. To inquire about the development of dialysis needs and mortality status, patients were contacted 30 days later to gather information.
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
- •Presented to the Emergency Department creatinine levels above the reference range (1.2 mg/dl in men and 1.1 mg/dl in women)
- •Underwent contrast-enhanced tomography
排除标准
- •Pregnancy
- •Known allergy history to contrast agents
- •Exposure to contrast agents within the last 72 hours
- •Being on dialysis due to end-stage kidney disease
- •Presenting with decompensated heart failure
- •Patients who were unable to provide informed consent
研究组 & 干预措施
Bolus hydration therapy
In the Bolus hydration therapy group, 500 ml of 0.9% saline treatment was started half an hour before the procedure and after the procedure, 1000 ml of 0.9% saline treatment was continued at a rate of 500 ml/h to be completed in 2 hours. A total of 1500 ml 0.9% saline hydration therapy was administered over 2.5 hours. According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol. In the bolus hydration group, 250 ml of treatment was administered half an hour before the procedure, and hydration was continued at a rate of 250 ml/h for 2 hours after the procedure.
干预措施: Bolus hydration therapy (Drug)
Continuous hydration therapy
In the Continuous hydration therapy group, saline treatment started 2 hours before the intravenous (IV) contrast agent application at a rate of 150 ml/h, and hydration was applied for 8 more hours after the procedure at the same rate. A total of 1500 ml 0.9% saline hydration therapy was administered over 10 hours. According to the literature, individuals with an ejection fraction of less than 40% got a half-dose hydration protocol. In the continuous hydration group, 75 ml/h of hydration was administered for 2 hours before the procedure and for 8 hours after the procedure.
干预措施: Continuous hydration therapy (Drug)
结局指标
主要结局
Rate of Participants Who Developed Contrast-Associated Acute Kidney Injury (CA-AKI)
时间窗: From enrollment to the end of treatment at 1 week
The primary outcome of our study was the development of CA-AKI, defined as an increase in serum creatinine value by ≥25% compared to baseline or an absolute increase in serum creatinine value by ≥0.5 mg/dL within 48-72 hours after contrast administration.
次要结局
- Rate of Participants Who Required Dialysis(From enrollment to the end of treatment at 1 month)
- All-Cause Mortality Rate(From enrollment to the end of treatment at 1 month)
研究者
Yunus Emre Gemici
MD
Gaziosmanpasa Research and Education Hospital