Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006465

Trial Description

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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

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Trial Acronym

HicoRhabdo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006465
  •   2015/04/14
  •   2011/11/04
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01467180  (ClinicalTrials.gov)
  •   CIV-11-06-000843 
  •   1490  (Gambro Dialysatoren GmbH)
  •   CIV-11-06-000843 
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Health Condition or Problem studied

  •   Rhabdomyolysis
  •   Renal Failure
  •   M62.89 -  [generalization M62.8: Other specified disorders of muscle]
  •   N17 -  Acute renal failure
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Interventions/Observational Groups

  •   Device: septeX
  •   Device: HF CVVH
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Myoglobin plasma level; time frame: 48h; 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.

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Secondary Outcome

- eGFR; time frame: 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); time frame: 6 month
- Duration of dialysis dependence (days); time frame: 6 month
- Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria; time frame: 6 month
- patient survival; time frame: 6 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/11/30
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Acute Rhabdomyolysis

- placed central venous catheter

- Indication for RRT due to Serum CK level > 15000 u/L

- Age ≥ 18 years

- Signed ICF

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Exclusion Criteria

- End stage CKD (dialysis dependent) renal failure before manifestation of
rhabdomyolysis

- Pregnancy or lactation

- Palliative treatment

- Participation in other clinical studies

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Addresses

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    • Gambro Dialysatoren GmbH
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    • Kai Zacharowski, MD 
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    • Kai Zacharowski, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.