Investigating Different Anticoagulants for Renal Replacement Therapy
- Registration Number
- NCT02669589
- Lead Sponsor
- University Hospital Muenster
- Brief Summary
The aim of this study is to evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.
- Detailed Description
Purpose of clinical trial:
To evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.
Patient population: critically ill patients with acute kidney injury requiring renal replacement therapy.
Primary objective:
Anticoagulation of the extracorporeal circuit is required in continuous RRT (CRRT). To this date, it is not clear which anticoagulant should be used for CRRT. Regional citrate anticoagulation (RCA) for CRRT in critically ill patients with AKI prolongs filter life span and reduces 90-day all cause mortality by approximately 8% (from 48% to 40%) compared to systemic heparin anticoagulation for CRRT
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 638
-
Critically ill patients with clinical indication for CRRT (clinical decision to use continuous RRT due to hemodynamic instability)
Or
Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation
-
At least one of the following conditions
- Sepsis or septic shock
- Use of catecholamines (norepinephrine or epinephrine ≥ 0.1 µg/kg/min or norepinephrine ≥ 0.05 µg/kg/min + dobutamine (any dose) or norepinephrine ≥ 0.05 µg/kg/min + vasopressin (any dose) or epinephrine ≥ 0.05 µg/kg/min + norepinephrine ≥ 0.05 µg/kg/min)
- Refractory fluid overload: worsening pulmonary edema: PaO2/FiO2 < 300 mmHg and/or fluid balance > 10% of body weight)
-
18-90 years old
-
Intention to provide full intensive care treatment for at least 3 days
-
Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation
- 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 (intracranial hemorrhage, aneurysm of brain arteries) 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 procedures)) or injuries, active tuberculosis; infective endocarditis)
- Disease or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease)
- Dialysis-dependent chronic kidney insufficiency
- Need of therapeutic systemic anticoagulation
- Allergic reaction to one of the anticoagulants or ingredients, Heparin-induced thrombocytopenia
- AKI caused by permanent occlusion or surgical lesion of the renal artery
- AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis or postrenal obstruction
- Do-not-resuscitate order
- Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura
- Persistent and severe lactate acidosis in the context of an acute liver failure and/or shock
- Kidney transplant within the last 12 months
- Pregnancy and nursing period
- Abortus imminens
- No hemofiltration machine free for use at the moment of inclusion
- Participation in another clinical intervention trial in the last 3 months
- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- Persons held in an institution by legal or official order
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description citrate anticoagulation Citrate Regional anticoagulation of the continuous renal replacement therapy with citrate. Target posthemofilter ionized calcium level: 0.25-0.35 mmol/l heparin anticoagulation Heparin Systemic anticoagulation of the continuous renal replacement therapy with heparin. Dose will be titrated to maintain aPTT (activated partial thromboplastin time) between 45-60s)
- Primary Outcome Measures
Name Time Method CRRT-filter life span in hours during continuous renal replacement therapy up to 1 year It will be reported how long the filter will be used during CRRT
Overall survival in a 90day follow-up period 90 days
- Secondary Outcome Measures
Name Time Method Hospital length of stay in days up to 1 year Number of patients with administration of red blood cells intraoperative Major adverse kidney events day 28, 60, 90 and after 1 year after start of CRRT ICU length of stay in days up to 1 year The primary ICU stay will be documented.
duration of renal replacement therapy 1 year within 1 year after randomization
Bleeding complication intraoperative Rate of infection during primary ICU stay up to 1 year Complications of therapy intraoperative Number of participants with hemodialysis day 28, 60, 90 and 1 year after start of CRRT Recovery of renal function day 28, 60, 90 and 1 year after start of CRRT The recovery of renal function will be defined as composite endpoint consisting of lack of dialysis dependency and serum creatinine level no more than 0.5 mg/dl above the baseline value)
Mortality day 28, 60 and 1-year
Trial Locations
- Locations (31)
University Hospital Aachen
🇩🇪Aachen, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
HELIOS Klinikum Bad Saarow, Dept. of Intensive Care
🇩🇪Bad Saarow, Germany
Charité Berlin CCV, Medical Department, Division of Nephrology
🇩🇪Berlin, Germany
Evangelisches Klinikum Bethel gGmbH
🇩🇪Bielefeld, Germany
University Hospital Bonn, Dept.of Anesthesiology and Intensive Care Medicine
🇩🇪Bonn, Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum
🇩🇪Bochum, Germany
University Hospital Frankfurt, Dept. of Anesthesiology, Intensive-Care Medicine and Pain Therapy
🇩🇪Frankfurt, Germany
University Hospital Essen, Dept. for Nephrology
🇩🇪Essen, Germany
University Hospital Duesseldorf, Dept. of Anaesthesiology
🇩🇪Duesseldorf, Germany
University Hospital Düsseldorf, Dept. of Nephrology
🇩🇪Düsseldorf, Germany
University Hospital Erlangen
🇩🇪Erlangen, Germany
University Medicine Greifswald
🇩🇪Greifswald, Germany
University Medical Center Göttingen, Dept. for Anesthesiology
🇩🇪Göttingen, Germany
University Medical Center Hamburg-Eppendorf, Dept. of Intensive Care
🇩🇪Hamburg, Germany
University Hospital Halle, Dept. of Anesthesiology and Intensive Care
🇩🇪Halle (Saale), Germany
University Hospital Heidelberg, Dept. of Anesthesiology
🇩🇪Heidelberg, Germany
University Hospital Schleswig-Holstein, Campus Kiel, Dept. for Anaesthesiology and Intensive Care
🇩🇪Kiel, Germany
University Hospital Jena, Dept. of Anesthesiology and Intensive Care Medicine
🇩🇪Jena, Germany
Klinikum Köln-Merheim, Medizinische Klinik I
🇩🇪Köln, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Technical University of Munich University Hospital, Dept. for Anaesthesiology
🇩🇪München, Germany
University Hospital Muenster
🇩🇪Muenster, Germany
University Hospital Regensburg, Dept. of Surgery
🇩🇪Regensburg, Germany
Municipal Hospital Solingen, Dept. for Nephrology and General Internal Medicine
🇩🇪Solingen, Germany
University Hospital Tuebingen
🇩🇪Tuebingen, Germany
University Hospital Gießen, Dept. of Anesthesiology and Intensive Care
🇩🇪Gießen, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsmedizin Mainz
🇩🇪Mainz, Germany
Charité Berlin, Dept. of Anesthesiology and Intensive Care Medicine
🇩🇪Berlin, Germany
Charité Berlin CCM, Medical Department, Division of Nephrology
🇩🇪Berlin, Germany