Increased Adsorption Membranes During Cardiopulmonary Bypass

NCT02518087 | Completed DMC

• 1 other identifier: SIRAKI 02-2015
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

CPB; oXiris®; CSA-AKI; SIRS; Cytokines; LPS; AKI

Outcome Measures

Primary Outcomes (1)

• Non presence of CSA-AKI within the first 7 days after cardiac surgery.

  Participants who underwent cardiac surgery with no CSA-AKI within the first 7 days after cardiac surgery. CSA-AKI will be defined as at least AKI stage≥1 (according to AKI KDIGO classification) during the first 7 days of cardiac surgery. Patients with previous mild chronic kidney disease (CKD) will also be classified as CSA-AKI according to changes of creatinine respect to baseline creatinine or urine output decrease within the first 7 days after cardiac surgery.

  7 days

Secondary Outcomes (7)

• 90 day survival after cardiac surgery.

  90 days

• ICU length of stay after cardiac surgery.

  Participants will be followed for the duration of ICU stay, an expected average of 2 days.

• Cytokine circulatory levels during CPB and up to 24 hours after surgery.

  First 24 hours after cardiac surgery.

• Urinary and blood levels of NAD values after cardiac surgery.

  First 24 hours after cardiac surgery.

• Composite Creatinine and Urine output after cardiac surgery.

  7 days after cardiac surgery.

Study Arms (2)

CPB-oXiris®

EXPERIMENTAL

Non emergent cardiac surgery patients requiring expected CPB time \> 90 minutes: double valve replacement or valve replacement plus coronary arterial bypass graft (CABG).

Device: oXiris®

CPB-Standard

NO INTERVENTION

Non emergent cardiac surgery patients requiring expected CPB time \> 90 minutes: double valve replacement or valve replacement plus coronary arterial bypass graft (CABG).

Interventions

oXiris® DEVICE

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.

CPB-oXiris®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with more than 18 years old.
• Non emergent cardiac surgery patients requiring expected CPB time \> 90 minutes: double valve replacement or valve replacement plus coronary arterial bypass graft (CABG).
• Written informed consent from patient or legal surrogates.

You may not qualify if:

• Immunosuppressive treatment or steroids (prednisone \> 0.5 mg/kg/day or equivalent).
• Autoimmune disorder.
• Transplant receptor.
• Advanced Chronic Kidney Disease (CKD 4 or 5).
• Renal replacement therapy in the last 90 days.
• Documented intolerance to study device.
• Pregnancy.
• Coexisting illness with a high probability of death (inferior to 6 months).

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Hospital Germans TrÃ-es i Pujol de Badalona: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Baxter Healthcare Corporation: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (3)

Hospital German Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• Perez-Fernandez X, Ulsamer A, Camara-Rosell M, Sbraga F, Boza-Hernandez E, Moret-Ruiz E, Plata-Menchaca E, Santiago-Bautista D, Boronat-Garcia P, Gumucio-Sanguino V, Penafiel-Munoz J, Camacho-Perez M, Betbese-Roig A, Forni L, Campos-Gomez A, Sabater-Riera J; SIRAKI02 Study Group. Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial. JAMA. 2024 Nov 5;332(17):1446-1454. doi: 10.1001/jama.2024.20630.

  PMID: 39382234 BACKGROUND

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Joan Sabater Riera, MD PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Xosé L Perez-Fernandez, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Kathleen D Liu, MD PhD

  University California San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 7, 2015
• Study Start: September 1, 2016
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (3)