Acute Kidney Injury
Conditions
Keywords
CRRT, AKI, anticoagulation, KDIGO
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
Interventions
DRUGHeparin
DRUGCitrate
Sponsors
University of Leipzig
German Research Foundation
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. 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) 3. 18-90 years old 4. Intention to provide full intensive care treatment for at least 3 days 5. Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation
Exclusion criteria
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 (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) 2. Disease or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease) 3. Dialysis-dependent chronic kidney insufficiency 4. Need of therapeutic systemic anticoagulation 5. Allergic reaction to one of the anticoagulants or ingredients, Heparin-induced thrombocytopenia 6. AKI caused by permanent occlusion or surgical lesion of the renal artery 7. AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis or postrenal obstruction 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 order
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with administration of red blood cells | intraoperative | — |
| Complications of therapy | intraoperative | — |
| 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) |
| Number of participants with hemodialysis | day 28, 60, 90 and 1 year after start of CRRT | — |
| Mortality | day 28, 60 and 1-year | — |
| ICU length of stay in days | up to 1 year | The primary ICU stay will be documented. |
| Hospital length of stay in days | up to 1 year | — |
| 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 | — |
| Major adverse kidney events | day 28, 60, 90 and after 1 year after start of CRRT | — |
Other
| Measure | Time frame |
|---|---|
| glomerular filtration rate | Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation |
| serum creatinine level in mg/dL | Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation |
| SOFA Scores (Sepsis-related Organ Failure Assessment score) | day 1-14, 21 and 28 during ICU stay |
| plasma urea concentration in mg/dl | Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation |
Countries
Germany
Outcome results
None listed