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

Phase 2

Withdrawn

• Conditions: Rhabdomyolysis
• Interventions: Device: CytoSorb Device; Procedure: CVVH

• Registration Number: NCT02111018
• Lead Sponsor: CytoSorbents, Inc

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 available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Primary Completion: 2016-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CytoSorb Device	CytoSorb Device	-
CVVH	CVVH	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center; 🇺🇸 San Antonio, Texas, United States