Clinical Trial to Evaluate the Use of an Adsorption Membrane (oXiris®) During Cardiopulmonary Bypass Surgery

Summary

Patients whom require cardiopulmonary bypass (CPB) during surgery present systemic inflammatory response syndrome (SIRS) due to blood cell activation and cytokine release to circulation. SIRS can lead to organ dysfunction due to hemodynamic compromise (vasodilatation plus leak syndrome) and/or cytokine mediated cell injury. Renal dysfunction is a major adverse complication after CPB surgery. Investigators hypothesize that the use of an increased adsorption membrane (OXIRIS®) during CPB is safe and presents low technical complexity. The safe use of OXIRIS® will reduce cytokine circulatory levels therefore decreasing SIRS and its systemic effects specially those concerning renal function. Therefore, patients receiving (OXIRIS®) could potentially present less cardiac surgery-associated acute kidney injury (CSA-AKI), and lower intensive care unit (ICU) and hospital length of stay.

Conditions

• Cardiac Surgical Procedures
• Cardiopulmonary Bypass

Interventions

DEVICE

OXIRIS®

OXIRIS® membrane set is composed of a 1.5 m2 copolymer of acrylonitrile and sodium methylsulfonate (AN 69) with polyethylenimine treated surface and adhered heparin during set´s fabrication \[OXIRIS® (Baxter Gambro)\]. PrismafleX eXeed™ II (Hospal) with OXIRIS® set will then be connected to CPB circuit. Blood flow between 150-200 ml/min will be derivatised from the CPB circuit into the PrismafleX eXeed™ so that it all flows through OXIRIS® membrane. Flow, pressure and alarms will be controlled by PrismafleX eXeed™ independently from CPB circuit. OXIRIS® membrane will be only employed for adsorption (neither convection nor diffusion will be performed) during all CPB time.

Sponsors & Collaborators

• Gambro Renal Products, Inc.

  collaborator INDUSTRY

• Hospital Universitari de Bellvitge

  lead OTHER

Principal Investigators

• Xose Luis Perez Fernandez, MD · Hospital Universitari de Bellvitge

• Joan Sabater Riera, MD Ph.D · Hospital Universitari de Bellvitge

• Paola Cárdenas, MD · Hospital Universitari de Bellvitge

• Enric Boza, MD · Hospital Universitari de Bellvitge

• Erika Plata-Menchaca, MD · Institut d'Investigació Biomèdica de Bellvitge

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2015-10-31

Completion

2015-10-31

Countries

• Spain

Study Locations