Citrate Versus Heparin in Continuous Renal Replacement Therapy : Effect on Cardiovascular System and Clot Circuit in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Cardiac output
研究概览
简要总结
This study is a prospective, multicenter, open-label randomized trial comparing regional citrate anticoagulation (RCA) with heparin-free protocol. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode. The investigators measured hemodynamic changes at certain time points after starting CRRT (0, 6, 12, 24, 48, 72 hr).Levels of inflammatory cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-ɑ) were measured at day 1 and day 3
详细描述
Twenty patients were randomized into heparin group and 11 patients were in citrate group. The cardiac performance were not significantly different between 2 groups at every time point. The inflammatory cytokines declined similarly in both treatment arms. The maximum filter survivial time was longer in a RCA group but not reach statistically significant (44.64±26.56 hr vs p=0.693 in citrate and heparin free group respectively).There was no serious side effects dung both treatment arm even in the group of liver dysfunction patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
systemic random sampling (block of four). Group A was the citrate group while group B was heparin- free method.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •need for CRRT,
- •no contraindication to CRRT
排除标准
- •patients with previous history of chronic kidney disease (CKD) (baseline serum creatinine > 2 mg/dL (male) or > 1.5 mg/dL (female)
- •history of renal transplantation
- •known pregnancy
- •previous dialysis within 30 days
- •severe liver disease
- •end stage heart disease or untreatable malignancy
- •moribund patients with expected survival less than 30 days
- •previous use of heparin or other anticoagulant, antiplatelet within 7 day except use for deep vein thrombosis
- •active bleeding at the time of enrollment and/or severe coagulopathy
- •receiving blood or blood components prior to enrollment
- •hemoglobin less than 7.5 g/dL and/or platelet count less than 100,000/mm3
- •previous underlying clotting disorders such as hypercoagulable state
- •severe malnutrition (Body mass index (BMI ) less than 18)
- •underwent CRRT for other reasons besides acute kidney injury (AKI)
结局指标
主要结局
Cardiac output
时间窗: 72 hour
cm3/min
Systemic vascular resistance
时间窗: 72 hour
mmHg⋅min⋅mL-1
Cardiac index
时间窗: 72 hour
L/min/m2
Systemic vascular resistance index
时间窗: 72 hour
dynes · sec/cm5/m2
次要结局
- Filter life span(through study completion,an aveage of 72 hours)
- Changes of IL-6(day 1,day 3)
- Renal survival(28 day)
- Changes of IL-10(day 1,day 3)
- Mortality(28 day)
- Changes of IL-1β(day 1,day 3)
- Changes of IL-8(day 1,day 3)
- Changes of TNF-ɑ(day 1,day 3)
研究者
Thananda Trakarnvanich
Associate Professor
Bangkok Metropolitan Administration Medical College and Vajira Hospital