The Optimal Mode of Renal Replacement Therapy in Acute Kidney Injury (OMAKI) Study: A Pilot Randomized Controlled Trial of Convective Versus Diffusive Clearance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints.
研究概览
简要总结
Acute kidney injury (AKI) in the intensive care unit is common, devastating and costly. However, minimal evidence exists to guide the prescription of optimal renal replacement therapy (RRT). An important area of uncertainty surrounds the relative effects of convective versus diffusive modes of clearance. Although both clearance modes provide similar degrees of small molecule clearance, convective modes permit the enhanced clearance of larger-sized molecules which may mediate kidney and systemic toxicity in the setting of AKI.
Continuous renal replacement therapies (CRRTs) are frequently applied in critically ill patients with AKI. Convective clearance, as applied through continuous venovenous hemofiltration (CVVH) and diffusive clearance, as applied through continuous venovenous hemodialysis (CVVHD), may be readily compared in the context of patients receiving CRRT.
The purpose of this study is to examine the feasibility of conducting a larger study that will determine whether convective clearance (hemofiltration) confers improved outcomes as compared to diffusive clearance (hemodialysis) in patients with AKI.
详细描述
The optimal mode of clearance in critically ill patients with acute kidney injury (AKI) who require renal replacement therapy (RRT) is unclear. Although both convection (as provided by hemofiltration) and diffusion (as provided by hemodialysis) provide equivalent removal of small-sized molecules, hemofiltration offers the potential for removal of large molecules many of which may be toxic. Hemofiltration and hemodialysis have never been compared in a rigorous randomized trial to date.
Continuous renal replacement therapies (CRRT) are widely used in the management of critically ill patients with AKI and current CRRT technology provides a practical platform on which to compare convective and diffusive clearance. We hypothesize that continuous venovenous hemofiltration (CVVH)- at identical doses of small molecule clearance that are provided by the comparison treatment of continuous venovenous hemodialysis (CVVHD)- leads to improved patient outcomes.
This study is an unblinded pilot RCT designed to test the feasibility of conducting a subsequent large scale study that will assess whether CVVH leads to improved patient outcomes (ie, survival, renal recovery) as compared to CVVHD. Although we will be collecting the full array of patient-relevant data for up to 60 days following randomization, the main purpose of this pilot study is to demonstrate the feasibility of recruiting, treating and following patients for a study designed to test this hypothesis.
Patient Population
The recruitment target for this study is 75 patients.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (over 16 years of age) admitted to a participating ICU
- •Serum creatinine increase of ≥ 50% from baseline
- •Hemodynamic instability as defined by the cardiovascular component of the SOFA score of ≥ 1
- •Attending physician deems the patient a candidate for RRT for at least one of the following reasons:
- •Presence of oliguria, defined as a urine output of < 100 mL in the preceding 4 hours
- •metabolic acidosis (HCO3- < 15 mmol/L and pH < 7.25)
- •refractory hyperkalemia (K > 6.0 mmol/L)
- •azotemia (BUN > 50 mmol/L)
- •suspected uremic organ involvement (pericarditis, encephalopathy, neuropathy or myopathy)
排除标准
- •renal replacement therapy within the previous 2 months
- •presence of renal obstruction
- •receipt of a kidney transplant in the previous year
- •diagnosis of rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
- •indication for intermittent hemodialysis, specifically severe hyperkalemia, dialyzable drug or toxin
- •terminal illness with associated life expectancy less than 2 months
- •patients who are moribund
- •prior enrollment in this study
- •enrollment in a competing ICU interventional study
- •no CRRT machine available
- •acute renal replacement ongoing for > 36 hours
结局指标
主要结局
We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints.
时间窗: 60 days
次要结局
- Change in Sequential Organ Failure Assessment (SOFA) score.(7 days)
研究者
Ron Wald
Staff Physician/Scientist
Unity Health Toronto