Myoglobin Removal by High Cut-off CVVHD

Renal Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467180
• Other study ID #: 1490
• Secondary ID: CIV-11-06-000843
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: April 4, 2017
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency
• Rhabdomyolysis

Intervention

Device:
• septeX
continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h
• HF CVVH
continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

Locations

Country	Name	City	State
Germany	Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum	Frankfurt	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24h
Secondary	eGFR	Estimation of kidney function by estimated glomerular filtration rate (eGFR)	at 3 and 6 month after treatment
Secondary	Duration of hospital stay (days)and Duration of ICU stay (days)		6 month
Secondary	Duration of dialysis dependence (days)		6 month
Secondary	Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria		6 month
Secondary	patient survival		6 month