Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study). (OXICARD)

Oxiris membrane is an efficient tool for inflammatory cytokines adsorption. Cardiac surgery is followed by an inflammatory state mimicking sepsis. The investigators hypothesized that cytokine adsorption by Oxiris® membrane can attenuate the inflammatory response and thus decrease the microcirculation impairment that followed cardiac surgery.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Cardiac Event
• Intervention / Treatment: Device: Oxiris

Detailed Description

Oxiris membrane is an efficient tool for inflammatory cytokines adsorption. Cardiac surgery is followed by an inflammatory state mimicking sepsis. The investigators hypothesized that cytokine adsorption by Oxiris® membrane can attenuate the inflammatory response and thus decrease the microcirculation impairment that followed cardiac surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with more than 18 years old
• Elective cardiac surgery under CPB with an 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

Exclusion Criteria:

• Missing informed consent.
• Planned CPB hypothermia <32ºC
• Emergency surgery.
• Acute infective endocarditis.
• Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
• AIDS with a CD4 count of < 200/ μl
• 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.
• Inclusion in other ongoing study within the last 30 days.
• Pregnancy.
• Coexisting illness with a high probability of death (inferior to 6 months).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With Oxiris	Device: Oxiris; Oxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1
No Intervention: Without Oxiris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery		at 6 hours
Improvement in microcirculation flow with Oxiris® membrane during CPB time at 2 days after cardiac surgery		at 2 days
Decrease of myocardial infarction with Oxiris® membrane	Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality	at day 30
Decrease of stroke with Oxiris® membrane	Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality	at day 30
Decrease of ischemic mesenteric with Oxiris® membrane	Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality	at day 30
Decrease of cardiac arrest with Oxiris® membrane	Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality	at day 30
Decrease of sudden death with Oxiris® membrane	Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality	at day 30
Decrease of acute kidney injury with Oxiris® membrane	Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality	at day 30
Decrease of In-hospital mortality with Oxiris® membrane	Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality	30 days
Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time	catecholamine are dobutamine and norepinephrine	day 30
Decrease of Requirement for renal replacement therapy events with Oxiris® membrane		30 days
Sepsis-related Organ Failure Assessment (SOFA) score with Oxiris® membrane	The quick SOFA score (qSOFA) assists health care providers in estimating the risk of morbidity and mortality due to sepsis. The score ranges from 0 to 3 points. The presence of 2 or more qSOFA points near the onset of infection was associated with a greater risk of death or prolonged intensive care unit stay.	30 days
Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane	SAPS II was designed to measure the severity of disease for patients admitted to Intensive care units aged 18 or more. 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%. No new score can be calculated during the stay. If a patient is discharged from the ICU and readmitted, a new SAPS II score can be calculated. This scoring system is mostly used to: describe the morbidity of a patient when comparing the outcome with other patients. describe the morbidity of a group of patients when comparing the outcome with another group of patients	30 days
decrease of day number in ICU with Oxiris® membrane		30 days
decrease of hospital stay in days with Oxiris® membrane		30 days
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Decrease of syndecan-1 expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		day 1
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		day 2
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		day 1
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		day 2
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane		day 1
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		day 2
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane		one day
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		two days
Variation of endothelin concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of endothelin concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane	- Comparison endothelin from baseline and at the end of cardiac surgery, H6, day 1 and day2	one day
Variation of endothelin concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Variation of VEGF concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of VEGF concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Variation of VEGF concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Variation of myocardial strain from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of myocardial strain from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Variation of myocardial strain from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Variation of diastolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of diastolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Variation of diastolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days
Variation of systolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Variation of systolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Variation of systolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Baxter Healthcare Corporation

Publications and helpful links

General Publications

• Abou-Arab O, Huette P, Haye G, Guilbart M, Touati G, Diouf M, Beyls C, Dupont H, Mahjoub Y. Effect of the oXiris membrane on microcirculation after cardiac surgery under cardiopulmonary bypass: study protocol for a randomised controlled trial (OXICARD Study). BMJ Open. 2021 Jul 9;11(7):e044424. doi: 10.1136/bmjopen-2020-044424.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PI2019_843_0072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No