Myoglobin Removal by High Cut-off CVVHD (HicoRhabdo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01467180
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : April 5, 2017
Gambro Dialysatoren GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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.

Condition or disease Intervention/treatment Phase
Rhabdomyolysis Renal Failure Device: septeX Device: HF CVVH Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myoglobin Reduction by High Cut-off (HCO) Continuous Veno- Venous Hemodialysis (CVVHD) in Patients With Rhabdomyolysis and an Increased Risk for Acute Kidney Injury
Study Start Date : November 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: HCO CVVHD
treatment of rhabdomyolysis pts with septeX dialyzer
Device: septeX
continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h

Active Comparator: HF CVVH
treatment of rhabdomyolysis pts with standard high flux dialyzer
Device: HF CVVH
continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

Primary Outcome Measures :
  1. Myoglobin plasma level [ Time Frame: 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 :
  1. eGFR [ Time Frame: at 3 and 6 month after treatment ]
    Estimation of kidney function by estimated glomerular filtration rate (eGFR)

  2. Duration of hospital stay (days)and Duration of ICU stay (days) [ Time Frame: 6 month ]
  3. Duration of dialysis dependence (days) [ Time Frame: 6 month ]
  4. Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria [ Time Frame: 6 month ]
  5. patient survival [ Time Frame: 6 month ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01467180

Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Dialysatoren GmbH

Responsible Party: Baxter Healthcare Corporation Identifier: NCT01467180     History of Changes
Other Study ID Numbers: 1490
CIV-11-06-000843 ( Other Identifier: Eudamed )
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases