NCT02111018

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

March 19, 2014

Last Update Submit

April 6, 2023

Conditions

Rhabdomyolysis

Outcome Measures

Primary Outcomes (2)

  • Efficacy of device as measured by change in myoglobin

    30 days

  • Assessment of serious device or procedure-related adverse events

    30 days

Study Arms (2)

CVVH

ACTIVE COMPARATOR
Procedure: CVVH

CytoSorb Device

EXPERIMENTAL
Device: CytoSorb Device

Interventions

CytoSorb DeviceDEVICE
CytoSorb Device
CVVHPROCEDURE
CVVH

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Rhabdomyolysis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • 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
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2016

Last Updated

April 7, 2023

Record last verified: 2023-04

Locations

US(1)