Myoglobin Removal by High Cut-off CVVHD (HicoRhabdo)

March 11, 2025 updated by: Vantive Health LLC

Myoglobin Reduction by High Cut-off (HCO) Continuous Veno- Venous Hemodialysis (CVVHD) in Patients With Rhabdomyolysis and an Increased Risk for Acute Kidney Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR
Time Frame: at 3 and 6 month after treatment
Estimation of kidney function by estimated glomerular filtration rate (eGFR)
at 3 and 6 month after treatment
Duration of hospital stay (days)and Duration of ICU stay (days)
Time Frame: 6 month
6 month
Duration of dialysis dependence (days)
Time Frame: 6 month
6 month
Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria
Time Frame: 6 month
6 month
patient survival
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vantive Health LLC

Collaborators

Baxter Healthcare Corporation
Gambro Dialysatoren GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimated)

November 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1490
  • CIV-11-06-000843 (Other Identifier: Eudamed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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