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HicoRhabdo: Myoglobin Removal by High Cut-off CVVHD

Sponsor
Baxter Healthcare Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01467180
Collaborator
Gambro Dialysatoren GmbH (Industry)
16
Enrollment
1
Location
2
Arms
30
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: septeX
  • Device: HF CVVH
 N/A

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 Design

Study Type:
Interventional
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 :
Nov 1, 2011
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. eGFR [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) [6 month]

  3. Duration of dialysis dependence (days) [6 month]

  4. Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria [6 month]

  5. patient survival [6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum Frankfurt Hessen Germany 60590

Sponsors and Collaborators

  • Baxter Healthcare Corporation
  • Gambro Dialysatoren GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01467180
Other Study ID Numbers:
  • 1490
  • CIV-11-06-000843
First Posted:
Nov 8, 2011
Last Update Posted:
Apr 5, 2017
Last Verified:
Apr 1, 2017
Keywords provided by Baxter Healthcare Corporation
septeX
CVVH
CVHD
myoglobin
Additional relevant MeSH terms:
Rhabdomyolysis

Study Results

No Results Posted as of Apr 5, 2017