Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis | NCT02111018 | Trialant
WithdrawnInterventionalPhase 2Updated Apr 7, 2023
Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
ClinicalTrials.gov ID
NCT02111018
Lead Sponsor
CytoSorbents, IncINDUSTRY
Overall Status
Withdrawn
Study Type
Interventional
Phase
Phase 2
Enrollment
0Actual
Last Update Posted
Apr 7, 2023Actual
Start Date
Mar 2014
Primary Completion Date
Jun 2016Estimated
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.
Rhabdomyolysis
CytoSorb Device
CVVH
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center
San Antonio, Texas 78234, United States
Lead Sponsor
CytoSorbents, IncINDUSTRY
Collaborators
San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn CenterUNKNOWN