Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.

Inflammatory Response Clinical Trial

— Polaris  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05754294
• Other study ID #: AntheaH
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Anthea Hospital Bari
• Contact: Ignazio Condello, PhD
• Phone: +393204608352
• Email: ignicondello[@]hotmail.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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%

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Disorder
• Hemolysis
• Inflammatory Response
• Red Blood Cell Disorder

Intervention

Diagnostic Test:
• Polarization of red blood cells
Pre and perioperative data blood sample were collected for each patient 5 minutes (min) before the CPB start and 5 minutes before the end of the CPB for Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) and Plasma Free Hemoglobin (pFHb). At the end of CPB the residual blood from the extracorporeal circulation was treated with cell-saver and the treated and concentrated red blood cells were collected in a transfusion bag. Two milliliters (ml) was taken from the bag, one ml was subjected to a blood gas test for the evaluation of the Hemoglobin (Hb) content and one ml was subjected inside a cuvette to the release of positive ions (polarization) with a charge of 50 Millivolt (mV) for a time of 5 seconds through charge circuit, after the trend of the conserved charge was measured through a multimeter, instrument that can measure multiple electrical properties.

Locations

Country	Name	City	State
Italy	Anthea Hospital	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Anthea Hospital Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythrocytes Membrane Integrity	Conservation of charge after polarization	At the end of Cardiopulmonary Bypass
Primary	Erythrocyte Sedimentation Rate (ESR)	Inflammation	At the end of Cardiopulmonary Bypass
Primary	Plasma Free Hemoglobin (pFHb)	Hemolysis	At the end of Cardiopulmonary Bypass