Myoglobin Removal by High Cut-off CVVHD (HicoRhabdo)
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|ClinicalTrials.gov Identifier: NCT01467180|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rhabdomyolysis Renal Failure||Device: septeX Device: HF CVVH||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2014|
Experimental: HCO CVVHD
treatment of rhabdomyolysis pts with septeX dialyzer
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
- 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.
- eGFR [ Time Frame: 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) [ Time Frame: 6 month ]
- Duration of dialysis dependence (days) [ Time Frame: 6 month ]
- Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria [ Time Frame: 6 month ]
- patient survival [ Time Frame: 6 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467180
|Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum|
|Frankfurt, Hessen, Germany, 60590|