NCT01467180

Myoglobin Removal by High Cut-off CVVHD

Myoglobin Reduction by High Cut-off (HCO) Continuous Veno- Venous Hemodialysis (CVVHD) in Patients With Rhabdomyolysis and an Increased Risk for Acute Kidney Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.

Detailed description

Excess myoglobin in the circulation is a causative pathogenetic factor of rhabdomyolysis associated with acute kidney injury (AKI). The rapid elimination of myoglobin by standard dialysis membranes is limited to its molecular weight of 17.8kDa, although some removal can be achieved when a convective therapy is applied. Significant clearance for myoglobin has been reported for high flux membranes from \< 8 mL/min (5) up to 22 mL/h (CVVH) (10) and for high cut-off (HCO) membranes a mean clearance rate of 36.2 mL/min in HD mode (7) and 39.2 mL/h in CVVH mode (5). The use of high cut-off (HCO) continuous veno- venous hemodialysis (CVVHD) may constitute a novel therapeutic strategy for effectively reduction of myoglobin in the patient's serum to ameliorate the course of AKI. Previously, a case study of the removal of myoglobin by HCO-CVVH in one single patient with severe rhabdomyolysis was published.

Conditions

• Rhabdomyolysis
• Renal Failure

Interventions

Type	Name	Description
DEVICE	septeX	continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h
DEVICE	HF CVVH	continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2011-11-08
• Last updated: 2025-03-13

Locations

1 site across 1 country: Germany