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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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