Rhabdomyolysis
Conditions
Brief summary
Prospective, randomized non-blinded, controlled study to assess the feasibility of the CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring renal replacement therapy.
Interventions
DEVICECytoSorb Device
PROCEDURECVVH
Sponsors
San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
CytoSorbents, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is age 18-80 * Subjects present with rhabdomyolysis * Subject requires renal replacement therapy and has undergone adequate volume resuscitation * Subject is willing to comply with specified follow up requirements
Exclusion criteria
* Subject or their legal guardian either declines or cannot give informed consent * Subject is pregnant * Subject has been previously enrolled in this clinical study * Comorbid condition that may limit survival to ≤14 days * Comorbid condition that could confound study results * Subjects who are receiving immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of device as measured by change in myoglobin | 30 days |
| Assessment of serious device or procedure-related adverse events | 30 days |
Countries
United States
Outcome results
None listed