Myoglobin Removal by High Cut-off CVVHD (HicoRhabdo)

Vantive Health LLC

Status: Completed

Conditions: Rhabdomyolysis; Renal Failure

Treatments: Device: septeX; Device: HF CVVH

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467180

CIV-11-06-000843 (Other Identifier)

1490

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute Rhabdomyolysis
• placed central venous catheter
• Indication for RRT due to Serum CK level > 5000 u/L
• Age ≥ 18 years
• Signed ICF

Exclusion criteria

• End stage CKD (dialysis dependent) renal failure before manifestation of rhabdomyolysis
• Pregnancy or lactation
• Palliative treatment
• Participation in other clinical studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

HCO CVVHD

Experimental group

Description:

treatment of rhabdomyolysis pts with septeX dialyzer

Treatment:

Device: septeX

HF CVVH

Active Comparator group

Description:

treatment of rhabdomyolysis pts with standard high flux dialyzer

Treatment:

Device: HF CVVH