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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
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhabdomyolysis focused on measuring septeX, CVVH, CVHD, myoglobin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 4, 2011
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
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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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