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Completed

NCT Number: NCT01467180

Myoglobin Removal by High Cut-off CVVHD

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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Key information

Conditions

Rhabdomyolysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Muscular Diseases Musculoskeletal Diseases Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

septeX

Device

continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h

HF CVVH

Device

continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

Primary outcomes

  1. 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.

Secondary outcomes

  1. eGFR

    Time frame: 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)

    Time frame: 6 month

  3. Duration of dialysis dependence (days)

    Time frame: 6 month

  4. Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria

    Time frame: 6 month

  5. patient survival

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Dialysatoren GmbH

Registry information

Official study 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

Acronym: HicoRhabdo

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2011
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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