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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
638
CRRT-filter life span in hours
It will be reported how long the filter will be used during CRRT
Time frame: during continuous renal replacement therapy up to 1 year
Overall survival in a 90day follow-up period
Time frame: 90 days
ICU length of stay in days
The primary ICU stay will be documented.
Time frame: up to 1 year
Hospital length of stay in days
Time frame: up to 1 year
duration of renal replacement therapy
within 1 year after randomization
Time frame: 1 year
Bleeding complication
Time frame: intraoperative
Number of patients with administration of red blood cells
Time frame: intraoperative
Rate of infection
Time frame: during primary ICU stay up to 1 year
Major adverse kidney events
Time frame: day 28, 60, 90 and after 1 year after start of CRRT
Complications of therapy
Time frame: intraoperative
Recovery of renal function
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)
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University Hospital Aachen
Aachen, Germany
Klinikum Augsburg
Augsburg, Germany
HELIOS Klinikum Bad Saarow, Dept. of Intensive Care
Bad Saarow, Germany
Charité Berlin, Dept. of Anesthesiology and Intensive Care Medicine
Berlin, Germany
Charité Berlin CCM, Medical Department, Division of Nephrology
Berlin, Germany
Charité Berlin CCV, Medical Department, Division of Nephrology
Berlin, Germany
Evangelisches Klinikum Bethel gGmbH
Bielefeld, Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, Germany
University Hospital Bonn, Dept.of Anesthesiology and Intensive Care Medicine
Bonn, Germany
Klinikum Köln-Merheim, Medizinische Klinik I
Cologne, Germany
...and 21 more locations
Time frame: day 28, 60, 90 and 1 year after start of CRRT
Number of participants with hemodialysis
Time frame: day 28, 60, 90 and 1 year after start of CRRT
Mortality
Time frame: day 28, 60 and 1-year