Pilot trial: Renal replacement therapy in patients with acute kidney injury and rhabdomyolysis

Not Applicable

• Conditions: N17.0; M62.9; Acute renal failure with tubular necrosis; Disorder of muscle, unspecified

• Registration Number: DRKS00023998
• Lead Sponsor: niversitätsklinikum Leipzig AöR Interdisziplinäre Internistische Intensivmedizin Leiter: Prof. Dr. med. Sirak Petros

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Study Completion: 2024-03-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Informed consent
- Acute kidney injury requiring renal replacement therapy (according KDIGO guidelines)
- Plasma myoglobin level above 4000 µg

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
marginal mean of myoglobin clearance

Secondary Outcome Measures

Name	Time	Method
- Clearance of creatinine, urea, beta-2 microglobulin, Il-6, albumin after 1h, 6h, 12h and 24 hours<br>- Lifetime of extracorporeal circuit (filter lifetime)<br>- 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)) <br>- Clinical endpoints: <br>o ICU length of stay (days)<br>o ICU mortality <br>o Hospital mortality <br>o Mortality day 28 <br>o Mortality day 90<br>- Safety endpoints (Intervention period):<br>o Adverse events:<br>- Hypocalcemia <br>- Metabolic alkalosis <br>- Citrate accumulation <br>- Bleeding, requiring blood transfusion<br>- Heparin induced Thrombocytopenia (HIT)<br>- Catheter malfunction <br>o Severe adverse events: <br>- Treatment-associated life-threatening complication<br>- Dead of any cause during intervention