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

Surgery Clinical Trial

— OXICARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04201119
• Other study ID #: PI2019_843_0072
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Osama ABOU ARAB, MD, PhD
• Phone: +33 3 22 08 78 36
• Email: abouarab.osama[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Event
• Surgery

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Baxter Healthcare Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery		at 6 hours
Secondary	Improvement in microcirculation flow with Oxiris® membrane during CPB time at 2 days after cardiac surgery		at 2 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time	catecholamine are dobutamine and norepinephrine	day 30
Secondary	Decrease of Requirement for renal replacement therapy events with Oxiris® membrane		30 days
Secondary	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
Secondary	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
Secondary	decrease of day number in ICU with Oxiris® membrane		30 days
Secondary	decrease of hospital stay in days with Oxiris® membrane		30 days
Secondary	Decrease of syndecan-1 expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Decrease of syndecan-1 expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		day 1
Secondary	Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		day 2
Secondary	Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		day 1
Secondary	Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		day 2
Secondary	Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane		day 1
Secondary	Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		day 2
Secondary	Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane		one day
Secondary	Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		two days
Secondary	Variation of endothelin concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	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
Secondary	Variation of endothelin concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days
Secondary	Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Secondary	Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Secondary	Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Secondary	Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days
Secondary	Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Secondary	Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Secondary	Variation of VEGF concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of VEGF concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Secondary	Variation of VEGF concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Secondary	Variation of myocardial strain from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of myocardial strain from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Secondary	Variation of myocardial strain from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane		two days
Secondary	Variation of diastolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of diastolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Secondary	Variation of diastolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days
Secondary	Variation of systolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane		6 hours
Secondary	Variation of systolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane		one day
Secondary	Variation of systolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane		2 days