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

CytoSorbents

Status and phase: Withdrawn; Phase 2

Conditions: Rhabdomyolysis

Treatments: Device: CytoSorb Device; Procedure: CVVH

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02111018

CytoSorb 2013-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CVVH

Active Comparator group

Treatment:

Procedure: CVVH

CytoSorb Device

Experimental group

Treatment:

Device: CytoSorb Device