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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by CytoSorbents, Inc
Sponsor:
Collaborator:
San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
Information provided by (Responsible Party):
CytoSorbents, Inc
ClinicalTrials.gov Identifier:
NCT02111018
First received: March 19, 2014
Last updated: June 22, 2015
Last verified: June 2015
  Purpose
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 Intervention Phase
Rhabdomyolysis
Device: CytoSorb Device
Procedure: CVVH
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by CytoSorbents, Inc:

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

Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CVVH Procedure: CVVH
Experimental: CytoSorb Device Device: CytoSorb Device

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT02111018     History of Changes
Other Study ID Numbers: CytoSorb 2013-001
Study First Received: March 19, 2014
Last Updated: June 22, 2015

Additional relevant MeSH terms:
Rhabdomyolysis
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on March 28, 2017