Extracorporeal Therapy for the Removal of Myoglobin Using... | NCT02111018

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

NCT02111018

Sponsor

CytoSorbents, Inc

Status

Withdrawn

Last Update Posted

Apr 7, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Rhabdomyolysis

Interventions

CytoSorb Device
CVVH

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jun 2016Estimated

Completion Date

Not provided

First Submitted Date

Mar 19, 2014

First Submission Date that Met QC Criteria

Apr 7, 2014

First Posted Date

Apr 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2023

Last Update Posted Date

Apr 7, 2023Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
CVVH	Active Comparator		Procedure: CVVH
CytoSorb Device	Experimental		Device: CytoSorb Device

Name	Type	Description	Arm Group Labels	Other Names
CytoSorb Device	Device		CytoSorb Device
CVVH

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center		San Antonio	Texas	78234	United States

Condition Browse Module

MeSH Terms

ID	Term
D012206	Rhabdomyolysis

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided