Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury (FST-LIBERATE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- % of patients with Renal recovery
研究概览
简要总结
Currently, continuous renal replacement therapy (CRRT) is the main modality for renal support in critically ill patients with hemodynamic instability. Most studies have investigated the timing of RRT initiation. However, prolonged CRRT demonstrated the association of many unexpected events, such as catheter-related complications, catheter-related blood stream infection, hypotension, hypothermia, tachycardia, and atrial fibrillation. Up to now, there is a lack of evidence regarding the timing of withholding CRRT. The furosemide stress test (FST) is a tool that is easy to use and has more availability. The investigators aimed to apply FST to evaluate renal recovery compared with standard treatment in critically ill patients undergoing CRRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 20 year of age or older
- •Acute kidney injury (AKI) stage 3 according to Kidney Disease Improving Global Outcomes (KDIGO) classification with oliguria (urine <400 ml/day)
- •Initiate CRRT in ICU (medical ICU, surgical ICU, cardiac care unit) for at least 48 hours (time for initiation and modality of CRRT can adjust by clinician)
排除标准
- •Use any inotropic drug (norepinephrine, epinephrine, dopamine, dobutamine)
- •Blood urea nitrogen (BUN) >80 mg/dL
- •Serum K <3.5 or >5 mmol/L
- •Arterial potential of Hydrogen (pH) <7.3
- •Serum bicarbonate (HCO3) <15 mmol/L
- •Urine volume <400 or >2,100 mL/day
- •Urine creatinine clearance (CrCl) at 6 hours >20 mL/min
- •Previous chronic kidney disease (CKD) stage 5 or estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2
- •Previous RRT within 14 days
- •Kidney transplantation
- •Obstructive etiology for AKI
- •Toxin/drug that necessitates RRT
- •Allergy to furosemide
- •Moribund with expected death within 24 hours
- •Pregnancy
研究组 & 干预措施
Protocol based-furosemide stress test
Furosemide at 1.5 mg/kg intravenously
干预措施: Furosemide Injection (Drug)
Standard care
Standard CRRT care without furosemide use during treatment.
结局指标
主要结局
% of patients with Renal recovery
时间窗: 5 days
Free of RRT for at least 5 days
次要结局
- % of complication(28 days)
- Cost of RRT during hospitalization(28 days)
- RRT free days(28 days)
- % of patients with Mortality(28 days)
- Ventilator-free day(28 days)
- Day of Hospitalization(28 days)
研究者
Prit Kusirisin, MD
Principal investigator
Chiang Mai University