Critically ill patients with acute kidney injury MedDRA version: 20.0 Level: PT Classification code 10069339 Term: Acute kidney injury System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form: Anticoagulant and preservative solution for blood
Sponsors
University Hospital Muenster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Critically ill patients with clinical indication for CRRT o Urea serum levels > 150 mg/dl or o Potassium serum levels > 6 mmol/l or o Magnesium serum levels > 4 mmol/l or o Blood pH = 7.15 or o Urine production 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect of regional citrate anticoagulation (RCA) for CRRT in critically ill patients on filter life span and all cause 90-day mortality compared to systemic heparin anticoagulation for CRRT;Secondary Objective: Evaluation of the clinical impact of the intervention on - Length of ICU and hospital stay / 1 year all cause mortality - Renal replacement therapy - Safety of the intervention - Cost analysis of renal replacement therapy ;Primary end point(s): filter life span (hours) overall survival in a 90-day follow-up period (90-day all cause mortality);Timepoint(s) of evaluation of this end point: filter live span (hours) overall survival (days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • ICU length-of-stay and hospital length-of-stay • Duration of renal replacement therapy • Bleeding complications • Transfusion requirement • Rate of infection during primary ICU stay • Major adverse kidney events at day 28, 60, 90 and after 1 year • Complications of therapy during study treatment • Recovery of renal function and requirement for hemodialysis after day 28, 60, 90 and 1 year • SOFA Scores at day 1-14, 21 and 28 • 28-day, 60-day and 1-year all cause mortality • Selected laboratory parameters • Cost analysis of renal replacement therapy • Delivered and prescribed dose of CRRT • Adverse events Add-on study: • New Biomarkers of acute kidney injury and mediators modulating pro- and anti-inflammatory mediators will be analysed in the blood and urine collected in different centres ;Timepoint(s) of evaluation of this end point: - from study inclusion up to end of continuous renal replacement therapy - from study inclusion up to end of intensive care therapy or day 28 - 60 days after study inclusion - 90 days after study inclusion - 1 year after study inclusion | — |
Countries
Germany
Contacts
Public ContactDept. of Anesthesiology
University Hospital Muenster
Outcome results
None listed