STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,019
- 试验地点
- 155
- 主要终点
- All-cause Mortality.
研究概览
简要总结
The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:
- Improved survival (primary outcome); and
- Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days
详细描述
Acute kidney injury (AKI) is a common and devastating complication of critical illness. Once AKI is established, treatment is largely supportive and no intervention has been found to restore kidney function or improve overall survival. Renal replacement therapy (RRT), usually in the form of hemodialysis, is frequently needed to manage patients with severe AKI. Such patients have an in-hospital mortality that consistently exceeds 50% with delays in RRT initiation implicated as a possible contributor. A recent meta-analysis suggested that earlier initiation of RRT may improve survival, but this is based on data derived overwhelmingly from observational studies. The investigators recently completed a multi-centre randomized controlled pilot trial that confirmed the feasibility of allocating patients to two different strategies of RRT initiation. Patient recruitment and follow-up, as well as patient safety, were successfully demonstrated during the pilot phase of this research program. The optimal timing of RRT initiation is an existing knowledge gap and a clear priority for investigation.
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
- 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
- •Age ≥ 18 years
- •Admission to an intensive care unit (ICU)
- •Evidence of kidney dysfunction [serum creatinine ≥100 µmol/L (women) and ≥ 130 µmol/L (men)]
- •Evidence of severe AKI defined by at least 1 of the following 3 criteria:
- •i) ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization; OR ii) Achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization; OR iii) Urine output < 6.0 mL/kg over the preceding 12 hours
排除标准
- •Serum potassium > 5.5 mmol/L
- •Serum bicarbonate < 15 mmol/L
- •Presence of a drug overdose that necessitates initiation of RRT
- •Lack of commitment to ongoing life support (including RRT)
- •Any RRT within the previous 2 months (either acute or chronic RRT)
- •Kidney transplant within the past 365 days
- •Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 20 mL/min/1.73 m2
- •Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis
- •Clinician(s) caring for patient believe(s) that immediate RRT is mandated
- •Clinician(s) caring for patient believe(s) that deferral of RRT initiation is mandated
- •at their discretion, clinicians may administer a bolus of intravenous furosemide (ie, "furosemide stress test") and evaluate the subsequent urine output to help guide decision making regarding the likelihood of AKI progression
结局指标
主要结局
All-cause Mortality.
时间窗: 90 days following study randomization.
次要结局
- RRT Dependence(90 days following study randomization.)
- Composite of Death or RRT Dependence.(Measured at day 365.)
- Measurement of Estimated Glomerular Filtration Rate.(90 days following study randomization.)
- Measurement of Albuminuria.(90 days following study randomization.)
- Major Adverse Kidney Outcomes.(90 days following study randomization.)
- Mechanical Ventilation-free Days.(Measured from randomization through day 28.)
- Vasoactive Therapy-free Days(Measured from randomization through day 28.)
- ICU-free Days(Measured from randomization through day 28.)
- Hospitalization-free Days(Measured from randomization through day 90.)
- Death in ICU(Measured in-hospital and at day 28.)
- EuroQoL EQ-5D-5L.(Measured at day 90 and at day 365.)
- Health Care Costs.(Measured from baseline through day 365.)