Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- metabolic stability
研究概览
简要总结
Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore, researchers are seeking ways to minimize bleeding risks and ensure effective dialysis.
One medication used to thin the blood in the dialysis machine is citrate. Citrate has the advantage of having its blood-thinning properties quickly reversed by calcium in the patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most patients who received citrate for dialysis were administered the citrate in a separate infusion through an IV pump into the dialysis machine. This method requires complex monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very similar to the regular dialysis fluid that is used in this intensive care unit, except that this fluid already contains exactly the correct amount of citrate. Thus, this method does not require a separate pump for citrate and calculations to pump the citrate into the blood as it goes through the kidney machine. Having the citrate already contained in the dialysis fluid simplifies the procedure and reduces the possibility of calculation errors.
This study seeks to determine if this simplified means of providing blood thinning in the kidney machine also results in the correct balance of blood salts.
详细描述
Acute renal failure is common among the critically ill [1-3] , and is an independent contributor to morbidity and mortality [4,5]. Continuous renal replacement therapy (CRRT) is commonly used for renal replacement in this group. This requires an extracorporeal circuit, the maintenance of which requires anticoagulation. Heparin has been the most common anticoagulant used with CRRT. However, heparin exposure for CRRT is major risk after surgery or trauma. Citrate has been used as a regional anticoagulant for plasmapheresis and chronic dialysis for many years [12,13], and is increasingly being used for CRRT. Regional anticoagulation refers to the provision of anticoagulation within the extracorporeal circuit without any alteration in coagulation in the patient's systemic circulation. Calcium is a co-factor in coagulation. Citrate reduces levels of ionized calcium in blood of the extracorporeal circuit to levels where coagulation cannot occur. Once the blood is returned to the patient's systemic circulation, the calcium levels are restored and coagulation can occur again. Renal replacement solutions for CRRT using citrate anticoagulation, should be calcium-free. [14-19] Despite a reduced risk of bleeding, widespread adoption of citrate regional anticoagulation has been limited by a lack of commercially available calcium-free solutions and the complexity of many protocols. Part of this complexity is the requirement for a separate citrate infusion into the extracorporeal circuit to achieve regional anticoagulation. This simplified protocol provides citrate in the replacement fluid infused prefilter as both anticoagulant and as buffer.
To predict appropriate replacement rates, Hospal Gambro scientific laboratories have developed a calculation model to predict the physiological interactions between the components of the administered replacement- and hemodialysis fluids and the patient's complex metabolic system. These interactions are influenced, in large part, by systemic parameters such as blood-flow and ultrafiltration rates, and patient parameters, such as acid base-status and liver function. This calculation model needs clinical validation in respect to its ability to predict the outcome and narrow the margin of metabolic disturbances caused by the administration of citrate anticoagulation. A previous study of a similar replacement fluid using citrate 8 mmol/L and citric acid 4 mmol/L resulted in mild metabolic acidosis of minimal clinical significance in some subjects and so this study will evaluate a modified version of fluid containing citrate 10 mmol/L and citric acid 2 mmol/L which has been calculated to provide optimal metabolic balance.
Subjects:
Twenty patients in the General Systems ICU at the University of Alberta Hospital treated with CVVHDF using a Prisma-CFM machine will be studied.
Inclusion criteria:
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
- 17 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 17 and 80 years of age.
- •Intensive care unit patient.
- •Acute renal failure requiring continuous venovenous hemodiafiltration.
- •Likely to survive for at least 72 hours
排除标准
- •Age > 80 years
- •Need for systemic anticoagulation, fibrinolytic therapy or activated protein C
- •Acute or chronic hepatic failure
研究组 & 干预措施
A
Critically ill patients with acute renal failure requiring continuous renal replacement therapy
干预措施: Regional citrate anticoagulation (Drug)
结局指标
主要结局
metabolic stability
时间窗: 24, 48 and 72 hours
次要结局
- Hemofilter survival(24, 48 and 72 hours)
