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NCT02111018 Clinical Trial

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

Rhabdomyolysis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02111018
Other study ID # CytoSorb 2013-001
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date March 2014

Study information
Verified date April 2023
Source CytoSorbents, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CytoSorb Device

Procedure:
• CVVH

Locations
Country Name City State
United States San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center San Antonio Texas

Sponsors (2)
Lead Sponsor Collaborator
CytoSorbents, Inc San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of device as measured by change in myoglobin 30 days
Primary Assessment of serious device or procedure-related adverse events 30 days
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