RhabdomyolysisPhase 2NCT02111018
Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
A Phase 2 study testing CytoSorb Device and CVVH in people with Rhabdomyolysis, run by CytoSorbents, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rhabdomyolysis
- What is being tested?
- CytoSorb Device and CVVH
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center
San Antonio, Texas, 78234
About this study
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.
- Conditions
- Rhabdomyolysis
- Being tested
- CytoSorb Device, CVVH
- Medical subject headings
- Rhabdomyolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb DeviceDevice
CVVHProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CVVH | Active comparator | Not described Receives: Procedure: CVVH |
| CytoSorb Device | Experimental | Not described Receives: Device: CytoSorb Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of device as measured by change in myoglobin
Measured: 30 days
Assessment of serious device or procedure-related adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2016 (estimated)
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
- Responsible party
- Sponsor
- Investigators
- LTC Kevin Chung, MD, Principal investigator, San Antonio Military Medical Center-US Army Institute of Surgical Research-Burn CenterMAJ Ian Stewart, MD, Principal investigator, San Antonio Military Medical Center-US Army Institute of Surgical Research- Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111018
- Sponsor's protocol ID
- CytoSorb 2013-001
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2014
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
- ClinicalTrials.gov ID
- NCT02111018
- Acronym / sponsor ID
- CytoSorb 2013-001
- Conditions
- Rhabdomyolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CytoSorbents, IncIndustry (pharma, biotech, devices)
- Collaborators
- San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVVH | Active comparator | Procedure: CVVH |
| CytoSorb Device | Experimental | Device: CytoSorb Device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorb Device | Device | CytoSorb Device |
| CVVH | Procedure or surgery | CVVH |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LTC Kevin Chung, MD principal investigator
San Antonio Military Medical Center-US Army Institute of Surgical Research-Burn Center
MAJ Ian Stewart, MD principal investigator
San Antonio Military Medical Center-US Army Institute of Surgical Research- Burn Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CytoSorb Device and CVVH in people with Rhabdomyolysis, run by CytoSorbents, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of device as measured by change in myoglobin (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.