NCT02398019

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

March 16, 2015

Last Update Submit

August 10, 2018

Conditions

Cardiac Surgical ProceduresCardiopulmonary Bypass

Keywords

CPBoXiris®SIRSAKICytokinesCSA-AKI

Outcome Measures

Primary Outcomes (2)

  • Safety with the use of CPB. Number of complications reported.

    Patients who underwent cardiac surgery with no related complications due to CPB (0 complications). Complications will be defined as those adverse effects related to technique that need an extra attention out of standard proceedings.

    24 hours

  • Cell-free serum hemoglobin

    Cell-free serum hemoglobin concentration will be measured in order to evaluate intravascular hemolysis. Determinations will be measured at T1 (CPB end), and T3 (24hours).

    24 hours

Secondary Outcomes (2)

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

    24 hours

  • Creatinine and Urine output after cardiac surgery.

    7 days

Study Arms (2)

CPB-OXIRIS®

EXPERIMENTAL

Non emergent cardiac surgery patients with CPB requirement.

Device: OXIRIS®

CPB-Standard

NO INTERVENTION

Non emergent cardiac surgery patients with CPB requirement.

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 \[OXIRIS® (Baxter Gambro)\]. 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.

CPB-OXIRIS®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with more than 18 years old.
  • Non emergent cardiac surgery requiring CPB.
  • Written informed consent from patient or legal surrogates

You may not qualify if:

  • Missing informed consent.
  • Planned CPB hypothermia \<32ºC or cardiac arrest.
  • Emergency surgery.
  • Acute infective endocarditis.
  • 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 (RRT) in the last 90 days.
  • Documented intolerance to study device.
  • Pregnancy.
  • Coexisting illness with a high probability of death (inferior to 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Study Officials

  • Xose Luis Perez Fernandez, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

  • Joan Sabater Riera, MD Ph.D

    Hospital Universitari de Bellvitge

    STUDY DIRECTOR

  • Paola Cárdenas, MD

    Hospital Universitari de Bellvitge

    STUDY CHAIR

  • Enric Boza, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

  • Erika Plata-Menchaca, MD

    Institut d'Investigació Biomèdica de Bellvitge

    PRINCIPAL INVESTIGATOR

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

March 16, 2015

First Posted

March 25, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

ES(1)