N17.0 M62.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Informed consent - Acute kidney injury requiring renal replacement therapy (according KDIGO guidelines) - Plasma myoglobin level above 4000 µg
Exclusion criteria
Exclusion criteria: - Refuse to participate - Rejection of renal replacement therapy - Age < 18 years - Contraindication for renal replacement therapy, for example end-stage underlying disease - Preexisting end stage kidney disease (CKD G5)/chronic intermittent hemodialysis - Pregnancy and lactation - Participation in other treatment studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| marginal mean of myoglobin clearance | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clearance of creatinine, urea, beta-2 microglobulin, Il-6, albumin after 1h, 6h, 12h and 24 hours - Lifetime of extracorporeal circuit (filter lifetime) - 90 day outcome: Composite endpoint of patient dead, persistent loss of renal function requiring dialysis or persistent decline in GFR (Slope >10 ml/min/1.72m2 (CKD-EPI)) - Clinical endpoints: o ICU length of stay (days) o ICU mortality o Hospital mortality o Mortality day 28 o Mortality day 90 - Safety endpoints (Intervention period): o Adverse events: - Hypocalcemia - Metabolic alkalosis - Citrate accumulation - Bleeding, requiring blood transfusion - Heparin induced Thrombocytopenia (HIT) - Catheter malfunction o Severe adverse events: - Treatment-associated life-threatening complication - Dead of any cause during intervention | — |
Countries
Germany
Contacts
Universitätsklinikum Leipzig AöR Interdisziplinäre Internistische Intensivmedizin Leiter: Prof. Dr. med. Sirak Petros