Clinical trial NCT05754294: Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
Official title: Electric Polarization of Red Blood Cells "Polaris": A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Conventional and Minimally Invasive Cardiac Surgery Procedures and The Related Perfusion Techniques
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Inflammatory Response
Erythrocyte Destruction
Red Blood Cell Disorder
Hemolysis
Cardiovascular Disorder
Lead sponsor: Anthea Hospital Bari
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Have been collected a perspective cohort of Eighty elective Cardiac Surgery procedures with Cardiopulmonary bypass (CPB) in a single tertiary institution Anthea Hospital Gvm Care \& Research, Bari, Italy. Forty patients were treated for Coronary Artery Bypass Grafting (CABG) of which (n=20), were allocated for Conventional Cardiopulmonary Bypass (cCPB) and (n=20), were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III. Forty patients were treated for Minimally Invasive Mitral Valve Repair (MIMVR); (n=20), reported a CPB time (\< 60 min.) and (n=20), a CPB time (\>100 min.).

Brief summary: An immediate perioperative parameter that assess the integrity of the Erythrocytes Membrane and therefore their structural quality isn't available in clinical practice and medical diagnostics except through indirect clinical biochemical tests or through the scanning electron microscope. The red blood cell (RBC) membrane contains proteins and glycoproteins embedded in a fluid lipid bilayer that confers viscoelastic behavior. Sialylated glycoproteins of the RBC membrane are responsible for a negatively charged surface which creates a repulsive electric zeta potential (ζ) between cells. These charges help prevent the interaction between RBCs and the other cells and especially between each other. The zeta potential is a physical property which is exhibited by all particles in suspension. The development of a net charge on any particle affects the distribution of ions in the surrounding interfacial region resulting in an increased concentration of counter ions of opposite charge to that of the particle, close to the surface. In this context we present a new parameter that studies the interactions of the Erythrocytes membrane treated with positive ions and their maintenance of the charge. We compared the measured polarization values with the Erythrocyte Sedimentation Rate (ESR), expression of speed with which RBCs tend to settle inside a particular graduated capillary called Westergren's tube and Plasma Free Hemoglobin (pFHb).


Eligibility criteria: Inclusion Criteria:

* Elective, primary cardiac surgery
* Minimally invasive cardiac surgery
* Mitral Valve Surgery (MVS)
* Conventional cardiac surgery (CCS)
* Coronary Arterial Bypass Grafting (CABG).

Exclusion Criteria:

* Abnormal plasma lactate levels (\>2 mmol/L)
* Renal
* Liver failure,
* Obesity,
* Uncompensated diabetes,
* Autoimmune disease, active infection
* Immunosuppressant therapy
* Coagulation disorder
* Surgery with circulatory arrest
* Preoperative hematocrit (Hct) \<27%

Primary outcomes:
measure: Erythrocytes Membrane Integrity
timeFrame: At the end of Cardiopulmonary Bypass
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: At the end of Cardiopulmonary Bypass
measure: Plasma Free Hemoglobin (pFHb)
timeFrame: At the end of Cardiopulmonary Bypass
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Anthea Hospital
Study officials:
References: