The Prevention of Acute Kidney Injury Following Contrast-Enhanced Computed Tomography: A Pilot Trial of Oral Fluid Versus Intravenous Saline
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility (recruitment rate, adherence to intervention and completeness of follow-up)
研究概览
简要总结
The purpose of this pilot trial is to determine the safety and feasibility of using oral salt and water loading compared to intravenous saline for the prevention of contrast-induced acute kidney injury in patients with chronic kidney disease receiving a contrast-enhanced CT scan.
详细描述
Background: Intravenous saline is the accepted prophylactic measure for prevention of contrast-induced acute kidney injury. However, most trials for contrast nephropathy prevention have been in the setting of arterial contrast, such as with cardiac catheterization, and not with venous contrast, such as computed tomography (CT). There is insufficient data on effective prophylactic strategies to prevent acute kidney injury (AKI) following contrast-enhanced CT scans.
Objective: The primary aim of this pilot trial is to determine the safety and feasibility of using oral salt and water loading compared to intravenous saline for the prevention of contrast-induced acute kidney injury in patients with chronic kidney disease (CKD) receiving a contrast-enhanced CT scan of the chest or abdomen. The results of the pilot trial will help us to plan and carry out a definitive efficacy trial to compare the two interventions.
Design: A randomized controlled trial with two parallel arms.
Study Population: 50 patients with chronic kidney disease (eGFR < 45 mL/min/1.73m2) who are undergoing a contrast-enhanced CT scan.
Intervention: Participants will be randomly allocated to receive either intravenous saline or oral salt and water loading. All participants will be administered an intravenous low-osmolar contrast medium as per recommended guidelines.
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
- Single (Outcomes Assessor)
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
- •Chronic kidney disease (as defined by glomerular filtration rate (GFR) < 45 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula calculated on the day of randomization);
- •Undergoing an outpatient intravenous contrast-enhanced CT of the chest or abdomen;
- •Age ≥ 18 years
- •Exclusion criteria:
- •Inability to give informed consent;
- •Previously enrolled in this study;
- •Any contrast-enhanced test in previous 14 days (to exclude patients who might have ongoing AKI from previous contrast exposure) ;
- •Congestive heart failure defined as New York Heart Association (NYHA) class III or worse 76;
- •Uncontrolled hypertension defined as systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at screening;
- •Receiving dialysis treatments.
- •The Physician ordering the CT scan has also ordered IV Saline, sodium bicarbonate or n-acetyl cysteine.
排除标准
- 未提供
研究组 & 干预措施
Oral Salt and Water
Oral Salt and Water Loading:
Participants randomized to this arm of the trial will receive 0.1 g/kg of salt (NaCl) and 12 mL/kg of water. Patients weighing more than 110 kg will receive the same amount as per a 110 kg patient. One third of the oral salt and water will be given before the CT and 2/3 post-CT as in the intravenous saline arm. Specifically, 0.03 g/kg of NaCl and 4 mL/kg of water in the one hour before CT and 0.07 g/kg of NaCl and 8 mL/kg of water taken over 2 hours post-CT. The ingestion of the oral salt and water will be directly observed by the study nurse to ensure adherence to the protocol.
干预措施: Oral Salt and Water (Biological)
Intravenous Saline
Patients randomized to this arm will receive intravenous isotonic (0.9%) saline. The rate of isotonic saline will be 3 mL/kg give in the one hour before CT and 1 mL/kg/hour for 6 hours post-CT as per Canadian guidelines. Patients weighing more than 110 kg will receive the rate as per a 110 kg patient. The dose will be rounded up to the nearest 5 mL.
干预措施: Intravenous Saline (Drug)
结局指标
主要结局
Feasibility (recruitment rate, adherence to intervention and completeness of follow-up)
时间窗: 24 months
The primary outcome for this pilot trial is feasibility (recruitment rate, adherence to intervention and completeness of follow-up). We will aim to establish that 1. We can randomize 50 patients into this trial; 2. Trial participants have \>95% adherence to the fluid regimens and 3. After randomization, \<1% participants are lost to follow-up in terms of post-CT serum creatinine measurements.
次要结局
- Safety(24 months)