Investigating Different Anticoagulants for Renal Replacement Therapy (RICH)
Acute Kidney Injury
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring CRRT, AKI, anticoagulation, KDIGO
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
- University Hospital Aachen
- Klinikum Augsburg
- HELIOS Klinikum Bad Saarow, Dept. of Intensive Care
- Charité Berlin, Dept. of Anesthesiology and Intensive Care Medicine
- Charité Berlin CCM, Medical Department, Division of Nephrology
- Charité Berlin CCV, Medical Department, Division of Nephrology
- Evangelisches Klinikum Bethel gGmbH
- Universitätsklinikum Knappschaftskrankenhaus Bochum
- University Hospital Bonn, Dept.of Anesthesiology and Intensive Care Medicine
- University Hospital Duesseldorf, Dept. of Anaesthesiology
- University Hospital Düsseldorf, Dept. of Nephrology
- University Hospital Erlangen
- University Hospital Essen, Dept. for Nephrology
- University Hospital Frankfurt, Dept. of Anesthesiology, Intensive-Care Medicine and Pain Therapy
- University Hospital Gießen, Dept. of Anesthesiology and Intensive Care
- University Medicine Greifswald
- University Medical Center Göttingen, Dept. for Anesthesiology
- University Hospital Halle, Dept. of Anesthesiology and Intensive Care
- University Medical Center Hamburg-Eppendorf, Dept. of Intensive Care
- University Hospital Heidelberg, Dept. of Anesthesiology
- University Hospital Jena, Dept. of Anesthesiology and Intensive Care Medicine
- University Hospital Schleswig-Holstein, Campus Kiel, Dept. for Anaesthesiology and Intensive Care
- Klinikum Köln-Merheim, Medizinische Klinik I
- Universitätsklinikum Leipzig
- Universitätsmedizin Mainz
- University Hospital Muenster
- Technical University of Munich University Hospital, Dept. for Anaesthesiology
- Klinikum Nürnberg
- University Hospital Regensburg, Dept. of Surgery
- Municipal Hospital Solingen, Dept. for Nephrology and General Internal Medicine
- University Hospital Tuebingen
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
heparin anticoagulation
citrate anticoagulation
Systemic anticoagulation of the continuous renal replacement therapy with heparin. Dose will be titrated to maintain aPTT (activated partial thromboplastin time) between 45-60s)
Regional anticoagulation of the continuous renal replacement therapy with citrate. Target posthemofilter ionized calcium level: 0.25-0.35 mmol/l