A Prospective, Observational Study to Evaluate the Safety and Feasibility of Continuous Renal Replacement Therapy With Regional Citrate Anticoagulation in a Cohort Critical Ill Patients With Acute Kidney Injury and Presumed Absent Citrate Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the incidence of citrate intoxication
研究概览
简要总结
Use of regional citrate anticoagulation in an at risk population with decreased citrate metabolism. This study assesses the feasibility and safety of regional citrate anticoagulation in this population.
详细描述
Regional citrate anticoagulation (RCA) is the recommended anticoagulation strategy for continuous renal replacement therapy (CRRT). Traditionally, CRRT-RCA is not recommended in patients with advanced liver failure or in patients with severe hemodynamic shock due to the risk of citrate accumulation or citrate intoxication. However, since more than a decade more and more patients with advanced liver failure and severe hemodynamic shock undergo safely CRRT-RCA with an adapted CRRT protocol. The aim of this study is to evaluate the efficacy and safety of CRRT-RCA in patients with decreased citrate metabolism using an adapted protocol to maximize citrate elimination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Need for renal replacement therapy in the ICU with any of the following criteria:
- •anticipation of severely impaired citrate metabolism (serum lactate ≥ 5 mmol/l in patients with shock or requirement of a dextrose drip to prevent hypoglycemia or spontaneous INR > 3 and/or requirement of fresh frozen plasma to maintain INR < 3 in patients with cirrhosis or acute liver failure or acute on chronic liver failure)
- •development of citrate toxicity under CRRT with RCA due to worsening citrate metabolism
排除标准
- •Pregnancy
- •A known hypersensitivity to citrate compounds
- •Refusal of informed consent
研究组 & 干预措施
Citrate group
Patients needing continuous renal replacement therapy with absent or reduced citrate metabolism treated with regional citrate anticoagulation
干预措施: continuous renal replacement therapy with regional citrate anticoagulation (Device)
结局指标
主要结局
the incidence of citrate intoxication
时间窗: 96 hours
a. Citrate accumulation defined as a total/ionized calcium ratio \> 2,5 b. Citrate intoxication is defined as i. Total/ionized calcium \> 2,5 in combination with two of the following 1. Ionized calcium \< 0,8 in spite of calcium substitution 2. Increasing demand in calcium substitution during the last 8 hours 3. Presence of high anion gap metabolic acidosis
the incidence of refractory citrate intoxication
时间窗: 96 hours
citrate intoxication and need for alternative anticoagulation regime
次要结局
未报告次要终点
研究者
Walter Verbrugghe
MD
University Hospital, Antwerp