Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-11-06-000843 | Other Identifier | Eudamed |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gambro Dialysatoren GmbH | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCO CVVHD | Experimental | treatment of rhabdomyolysis pts with septeX dialyzer |
|
| HF CVVH | Active Comparator | treatment of rhabdomyolysis pts with standard high flux dialyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| septeX | Device | continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR | Estimation of kidney function by estimated glomerular filtration rate (eGFR) | at 3 and 6 month after treatment |
| Duration of hospital stay (days)and Duration of ICU stay (days) | 6 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum | Frankfurt am Main | Hesse | 60590 | Germany |
Not provided
| ID | Term |
|---|---|
| D012206 | Rhabdomyolysis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HF CVVH | Device | continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h |
|
| Duration of dialysis dependence (days) | 6 month |
| Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria | 6 month |
| patient survival | 6 month |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |