Increased Adsorption Membranes During Cardiopulmonary Bypass

Summary

Our project intends to reduce cardiac surgery associated - acute kidney injury (CSA-AKI) in non emergent patients with the use of an increased adsorption membrane (oXiris®) connected to the cardiopulmonary bypass (CPB) circuit, besides evaluating the inflammatory response by quantifying inflammatory mediators during and after cardiac surgery with CPB. Our study is a randomized and controlled multicentre trial that includes recruiting centres with a long experience in cardiac surgery with CPB.

The primary endpoint of the project is to evaluate the ability of oXiris® to reduce the incidence of CSA-AKI in patients undergoing non emergent cardiac surgery with an expected CPB time of more than 90 minutes (doble valve replacement or valve replacement plus coronary artery bypass graft). With the goal of reducing by 10% (from 25 to 15%) the risk of CSA-AKI during the first postoperative week a sample size of 340 patients has been calculated.

Secondary endpoints are two; first, to evaluate the effect of using oXiris® on survival, clinical course and removal capacity of cytokines and lipopolysaccharide (LPS) during and after CPB; and second, to assess the predictive value for CSA-AKI of some new biomarkers, such as uNAD (urinary nicotinamide adenine dinucleotide).

Conditions

• Cardiopulmonary Bypass
• Cardiac Surgery Associated - Acute Kidney Injury
• Systemic Inflammatory Response Syndrome
• Acute Kidney Injury

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 \[oXiris® (Baxter Gambro)\]. Blood flow between 200-250 mL/min will be derivatised from the CPB circuit (arterial positive pressure line just after the oxygenator) into the PrismafleX eXeed™, so that it all flows thru the oXiris® membrane and returned to the CPB circuit into the venous reservoir just before the oxygenator. oXiris® membrane will be only employed for adsorption (neither convection nor diffusion will be performed) during all CPB time.

Sponsors & Collaborators

• Hospital Germans TrÃ-es i Pujol de Badalona

  collaborator UNKNOWN

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  collaborator UNKNOWN

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Hospital Universitari de Bellvitge

  lead OTHER

Principal Investigators

• Joan Sabater Riera, MD PhD · Hospital Universitari de Bellvitge

• Xosé L Perez-Fernandez, MD · Hospital Universitari de Bellvitge

• Kathleen D Liu, MD PhD · University California San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2022-01-15

Completion

2022-01-15

Countries

• Spain

Study Locations