Myoglobin Removal by High Cut-off CVVHD (HicoRhabdo)
Primary Purpose
Rhabdomyolysis, Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
septeX
HF CVVH
Sponsored by
About this trial
This is an interventional treatment trial for Rhabdomyolysis focused on measuring septeX, CVVH, CVHD, myoglobin
Eligibility Criteria
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
Sites / Locations
- Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HCO CVVHD
HF CVVH
Arm Description
treatment of rhabdomyolysis pts with septeX dialyzer
treatment of rhabdomyolysis pts with standard high flux dialyzer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
eGFR
Estimation of kidney function by estimated glomerular filtration rate (eGFR)
Duration of hospital stay (days)and Duration of ICU stay (days)
Duration of dialysis dependence (days)
Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria
patient survival
Full Information
NCT ID
NCT01467180
First Posted
November 4, 2011
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01467180
Brief Title
Myoglobin Removal by High Cut-off CVVHD
Acronym
HicoRhabdo
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhabdomyolysis, Renal Failure
Keywords
septeX, CVVH, CVHD, myoglobin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCO CVVHD
Arm Type
Experimental
Arm Description
treatment of rhabdomyolysis pts with septeX dialyzer
Arm Title
HF CVVH
Arm Type
Active Comparator
Arm Description
treatment of rhabdomyolysis pts with standard high flux dialyzer
Intervention Type
Device
Intervention Name(s)
septeX
Intervention Description
continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h
Intervention Type
Device
Intervention Name(s)
HF CVVH
Intervention Description
continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h
Primary Outcome Measure Information:
Title
Myoglobin plasma level
Description
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.
Time Frame
24h
Secondary Outcome Measure Information:
Title
eGFR
Description
Estimation of kidney function by estimated glomerular filtration rate (eGFR)
Time Frame
at 3 and 6 month after treatment
Title
Duration of hospital stay (days)and Duration of ICU stay (days)
Time Frame
6 month
Title
Duration of dialysis dependence (days)
Time Frame
6 month
Title
Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria
Time Frame
6 month
Title
patient survival
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
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Myoglobin Removal by High Cut-off CVVHD
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