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临床试验/NCT01839578
NCT01839578Unknown不适用

Regional Citrate Versus Systemic Heparin Anticoagulation for Super High-flux Continuous Hemodialysis in Septic Shock: Effect on Middle Molecular Weight Molecules Clearances

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Middle molecular weight molecules clearances

研究概览

简要总结

Sepsis is responsible for 50% of all acute kidney injury (AKI) in intensive care units (ICUs), contributing greatly to multiple organ dysfunction syndrome (MODS). Special types of continuous renal replacement therapies (CRRT) have been proposed as adjuvant therapies for septic shock due to their ability to remove middle molecular weight molecules such as inflammatory mediators involved in MODS pathophysiology. These therapies are called extracorporeal " blood purification " therapies.

When CRRT is used, an anticoagulation is required to prevent clotting of the extracorporeal circuit, possibly causing bleeding in selected patients. Many anticoagulation strategies have been proposed and the most commonly used in 2013 is still unfractionated heparin. Regional citrate anticoagulation (RCA) is an interesting alternative as it dramatically decreases the bleeding risk.

The investigators hypothesize that the use of citrate with Super High Flux Continuous Veno-Venus Hemodialysis (SHF-CVVHD) would be highly beneficial over time by preserving the filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore sizes (protein cake)), as compared to heparin. Consequently, higher clearances of the inflammatory mediators could be maintained over time with citrate as compared to heparin anticoagulation. In other words, for the same duration of filter use, middle molecular weight molecules and cytokines clearances would be greater with citrate as compared to heparin. To test this hypothesis, the investigators will perform a clinical randomized controlled trial which aim would be to compare middle molecular weight molecules and cytokines clearances in SHF-CVVHD using RCA versus systemic heparin anticoagulation in septic patients with AKI.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female critically ill patients over the age of 18 years old
  • Acute Kidney Injury requiring CRRT defined using the Risk, Injury, Failure, Loss, End-stage renal disease (RIFLE) classification with criterion I or worse.
  • Septic shock as defined by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference.
  • Written informed consent obtained from the patient or a patient's legal representative
  • Patient patient's legal representative able to agree to patient's enrollment in the study with informed consent.

排除标准

  • Pregnancy
  • Participation in another research study protocol
  • Known heparin induced thrombopenia or contraindication to heparin
  • Pre-existing chronic renal failure on chronic dialysis
  • Therapeutic anticoagulation with heparin for another reason (e.g. chonic arrhythmia)
  • Severe liver failure (15% prothrombin time)

研究组 & 干预措施

RCA Group

Experimental

SHF-CVVHD with regional citrate anticoagulation

干预措施: Anticoagulation to prevent clotting of the extracorporeal circuit. (regional citrate anticoagulation) (Drug)

Heparin group

Experimental

SHF-CVVHD with systemic heparin anticoagulation

干预措施: Anticoagulation to prevent clotting of the extracorporeal circuit (Unfractionated heparin) (Drug)

结局指标

主要结局

Middle molecular weight molecules clearances

时间窗: 18 months

At each time point of the study (T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h), blood and post-filter samplings will be taken in order to calculate kappa and lambda light chains of immunoglobulin clearances.

次要结局

  • Clearances of cytokines and molecules of interest(T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h)
  • mortality(28th day)
  • Hemodynamic parameters(T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h)
  • Respiratory parameters((T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h),)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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