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

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ClinicalTrials.gov Identifier: NCT02111018
Recruitment Status : Unknown
Verified June 2015 by CytoSorbents, Inc.
Recruitment status was:  Recruiting
First Posted : April 10, 2014
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
Information provided by (Responsible Party):
CytoSorbents, Inc

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
Rhabdomyolysis Device: CytoSorb Device Procedure: CVVH Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : June 2016

Arm Intervention/treatment
Active Comparator: CVVH Procedure: CVVH
Experimental: CytoSorb Device Device: CytoSorb Device



Primary Outcome Measures :
  1. Efficacy of device as measured by change in myoglobin [ Time Frame: 30 days ]
  2. Assessment of serious device or procedure-related adverse events [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111018


Locations
United States, Texas
San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Ian Stewart, MD    210-916-6152    ian.j.stewart6.mil@mail.mil   
Sub-Investigator: MAJ Ian Stewart, MD         
Principal Investigator: LTC Kevin Chung, MD         
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

Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT02111018     History of Changes
Other Study ID Numbers: CytoSorb 2013-001
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Rhabdomyolysis
Muscular Diseases
Musculoskeletal Diseases