Myoglobin Removal by High Cut-off CVVHD

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01467180

Acronym

HicoRhabdo

Enrollment

Registered

2011-11-08

Start date

2011-11-30

Completion date

2014-05-31

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure, Rhabdomyolysis

Keywords

septeX, CVVH, CVHD, myoglobin

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.

Interventions

DEVICEsepteX

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

DEVICEHF CVVH

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026