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

Sponsor
CytoSorbents, Inc (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02111018
Collaborator
San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center (Other)
30
Enrollment
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CytoSorb Device
  • Procedure: CVVH
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CVVH

Procedure: CVVH
Experimental: CytoSorb Device

Device: CytoSorb Device

Outcome Measures

Primary Outcome Measures

  1. Efficacy of device as measured by change in myoglobin [30 days]

  2. Assessment of serious device or procedure-related adverse events [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center San Antonio Texas United States 78234

Sponsors and Collaborators

  • CytoSorbents, Inc
  • San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center

Investigators

  • Principal Investigator: LTC Kevin Chung, MD, San Antonio Military Medical Center-US Army Institute of Surgical Research-Burn Center
  • Principal Investigator: MAJ Ian Stewart, MD, San Antonio Military Medical Center-US Army Institute of Surgical Research- Burn Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CytoSorbents, Inc
ClinicalTrials.gov Identifier:
NCT02111018
Other Study ID Numbers:
  • CytoSorb 2013-001
First Posted:
Apr 10, 2014
Last Update Posted:
Jun 23, 2015
Last Verified:
Jun 1, 2015
Additional relevant MeSH terms:
Rhabdomyolysis

Study Results

No Results Posted as of Jun 23, 2015