Myoglobin Removal by High Cut-off CVVHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-05-31

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.

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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.

Conditions

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Rhabdomyolysis Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCO CVVHD

treatment of rhabdomyolysis pts with septeX dialyzer

Group Type EXPERIMENTAL

septeX

Intervention Type DEVICE

continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h

HF CVVH

treatment of rhabdomyolysis pts with standard high flux dialyzer

Group Type ACTIVE_COMPARATOR

HF CVVH

Intervention Type DEVICE

continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

Interventions

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septeX

continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h

Intervention Type DEVICE

HF CVVH

continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No