Back to resultsExtracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
Primary Purpose
Rhabdomyolysis
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CytoSorb Device
CVVH
Sponsored by
About this trial
This is an interventional treatment trial for Rhabdomyolysis
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
Sites / Locations
- San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CVVH
CytoSorb Device
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of device as measured by change in myoglobin
Assessment of serious device or procedure-related adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT02111018
First Posted
March 19, 2014
Last Updated
April 6, 2023
Sponsor
CytoSorbents, Inc
Collaborators
San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
1. Study Identification
Unique Protocol Identification Number
NCT02111018
Brief Title
Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoSorbents, Inc
Collaborators
San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhabdomyolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVVH
Arm Type
Active Comparator
Arm Title
CytoSorb Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CytoSorb Device
Intervention Type
Procedure
Intervention Name(s)
CVVH
Primary Outcome Measure Information:
Title
Efficacy of device as measured by change in myoglobin
Time Frame
30 days
Title
Assessment of serious device or procedure-related adverse events
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LTC Kevin Chung, MD
Organizational Affiliation
San Antonio Military Medical Center-US Army Institute of Surgical Research-Burn Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MAJ Ian Stewart, MD
Organizational Affiliation
San Antonio Military Medical Center-US Army Institute of Surgical Research- Burn Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
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