WithdrawnPhase 2

Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis

Stopped: Lack of enrollment

United States0Started 2014-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Efficacy of device as measured by change in myoglobin

Timeframe: 30 days

Assessment of serious device or procedure-related adverse events

Timeframe: 30 days

Trial details

NCT IDNCT02111018

SponsorCytoSorbents, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Rhabdomyolysis trials