Myoglobin Removal by High Cut-off CVVHD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rhabdomyolysis, Renal Failure

Intervention / Treatment
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* Device: septeX
* Device: HF CVVH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCO CVVHD<br>treatment of rhabdomyolysis pts with septeX dialyzer | Device: septeX<br>* continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h<br>|
| Active Comparator: HF CVVH<br>treatment of rhabdomyolysis pts with standard high flux dialyzer | Device: HF CVVH<br>* continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoglobin plasma level | 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. | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR | Estimation of kidney function by estimated glomerular filtration rate (eGFR) | at 3 and 6 month after treatment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septeX, CVVH, CVHD, myoglobin