Myoglobin Removal by High Cut-off CVVHD

Not Applicable

Completed

• Conditions: Renal Failure; Rhabdomyolysis
• Interventions: Device: septeX; Device: HF CVVH

• Registration Number: NCT01467180
• Lead Sponsor: Vantive Health LLC

Brief 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCO CVVHD	septeX	treatment of rhabdomyolysis pts with septeX dialyzer
HF CVVH	HF CVVH	treatment of rhabdomyolysis pts with standard high flux dialyzer

Primary Outcome Measures

Name	Time	Method
Myoglobin plasma level	24h	Two fold- increased reduction of myoglobin plasma level in favor of the HCO CVVHD group compared with standard therapy group (HF-CVVH and fluid therapy, respectively) after 48 hours treatment time.

Secondary Outcome Measures

Name	Time	Method
eGFR	at 3 and 6 month after treatment	Estimation of kidney function by estimated glomerular filtration rate (eGFR)
Duration of hospital stay (days)and Duration of ICU stay (days)	6 month
Duration of dialysis dependence (days)	6 month
Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria	6 month
patient survival	6 month

Trial Locations

Locations (1)

Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum; 🇩🇪 Frankfurt, Hessen, Germany