EUCTR2014-004854-33-DE进行中（未招募）1 期
Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH-Trial). - RICH-Trial
niversity Hospital Muenster0 个研究点目标入组 1,450 人开始时间: 2015年11月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Critically ill patients with clinical indication for CRRT
- •oUrea serum levels > 150 mg/dl or
- •oPotassium serum levels > 6 mmol/l or
- •oMagnesium serum levels > 4 mmol/l or
- •oBlood pH = 7.15 or
- •oUrine production < 200 ml/12 h or anuria or
- •oOrgan edema in the presence of AKI resistant to diuretic treatment
- •Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation
- •2.At least one of the following conditions
- •oSepsis or septic shock
- •oUse of catecholamines (norepinephrine or epinephrine = 0.1 µg/kg/min or norepinephrine = 0.05 µg/kg/min + dobutamine or norepinephrine = 0.05 µg/kg/min + vasopressin or norepinephrine = 0.05µg/kg/min + epinephrine =0.05µg/kg/min)
- •oRefractory fluid overload: worsening pulmonary edema: PaO2/FiO2 < 300 mmHg and/or fluid balance > 10% of body weight)
- •3.18-90 years old and
- •4.Intention to provide full intensive care treatment for at least 3 days and
- •5.Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 580
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 870
排除标准
- •1. Patients with increased bleeding risk (e.g. an active bleeding from ulcers in the gastro-intestinal tract, hypertension with a diastolic blood pressure higher than 105 mm Hg, injuries of or surgical procedures on the central nervous system if a heparinization with a target aPTT 45-60 s is not allowed by the treating neurologist or neurosurgeon, severe retinopathies, bleeding into the vitreum, ophthalmic surgical procdures or injuries, active tuberculosis, infective endocarditis)
- •2. Diseases or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease)
- •3. Dialysis-dependent chronic kidney insufficiency
- •4. Need of therapeutic anticoagulation (PTT > 60s, antiXa > 0.6 IE/ml, INR > 2)
- •5. Allergic reaction to one of the anticoagulantia, or ingredients, Heparin-induced thrombocytopenia
- •6. AKI caused by permanent occlusion or surgical lesion of both renal arteries
- •7. AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis
- •8. Do-not-resuscitate order
- •9. Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura
- •10. Persistent and severe lactate acidosis in the context of an acute liver failure and/or shock
- •11. Kidney transplant within the last 12 months
- •12. Pregnancy and nursing period
- •13. Abortus imminens
- •14. No hemofiltration machine free for use at the moment of inclusion
- •15. Participation in another clinical intervention trial in the last 3 months
- •16. Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- •17. Persons held in an institution by legal or official ordner
研究者
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