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
- 1
- 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)
研究组 & 干预措施
Citrate
The RCA group CRRT were performed with Prisma flex or (Baxter Healthcare/Gambro Spain) or Informed machine with citrate pump. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in postdilution mode with ST 150 filter sets. The substitution fluid was Accusol or Prismocal B22 .The dose of dialysis was 20-25 ml/kg/hr with blood flow 150-200 ml/min. Trisodium citrate solution (4%,136mmol/L) was infused into the arterial line prior to the blood pump at a dose of 4 mmol/L of plasma flow. Calcium chloride (5% 340 mmol/L elemental calcium) was infused into the venous return to maintain systemic ionized calcium in the normal range (0.99-1.30 mmol/L) and the targets values for ionized calcium (iCa2+) after the dialysis membrane were 0.25-0.35 mmol/L. The rale of calcium infusion was adjusted in a timely manner based on repeated measurements of calcium concentration
干预措施: Regional citrate anticoagulation (Procedure)
Heparin-free
The heparin- free group The circuit was periodically flushed with 50 ml saline via access limb every 30 minutes .When pre-filter pressure started to rise, additional saline flushes would be given.
干预措施: Regional citrate anticoagulation (Procedure)
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
- Changes of IL-10(day 1,day 3)
- Filter life span(through study completion,an aveage of 72 hours)
- Changes of IL-6(day 1,day 3)
- Renal survival(28 day)
- 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