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

April 6, 2023 updated by: CytoSorbents, Inc
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78234
        • San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CVVH
Procedure: CVVH
Experimental: CytoSorb Device
Device: CytoSorb Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of device as measured by change in myoglobin
Time Frame: 30 days
30 days
Assessment of serious device or procedure-related adverse events
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoSorbents, Inc

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CytoSorb 2013-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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