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The effect of blood flow type in the heart_lung machine on the balance between harmful and protective substance in adults undergoing open_heart surgery

The effect of using pulsatile versus non_pulsatile blood flow during cardiopulmonary bypass on oxidant_antioxidant balance in adult patients endergoing coronary artery bypass grafting surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250405065210N1
Enrollment
50
Registered
2025-05-13
Start date
2025-05-19
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease. Atherosclerotic heart disease of native coronary artery

Interventions

Intervention 1: Intervention group: Group B Pulsatile flow perfusion is established with a Sorin
Stockert ? roller pump, and perfusion is maintained between 2.8-2.2 L/min/m2 of patient body surface area. Pulsatile perfusion for adults is set internally with non-ECG-synchronized pulsatile blood pu
Stockert ? roller pump, and perfusion will be maintained between 2.2-8 liters/minute/square meter of the patients body surface area.

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: All adult patients between the ages of 40 and 80 years who are referred to Imam Reza (AS) Cardiac Surgery Center, Mashhad, Iran for coronary artery bypass graft surgery using ON-CPB and Who consent to participate in the study

Exclusion criteria

Exclusion criteria: Redo Surgery. Patients with poor cardiac function with EF less than 35% Liver dysfunction with SGOT or SGPT elevation greater than 1.5 times the normal baseline levelPresence of coagulation disorders before surgery Lack of written consent for study entryPresence of preoperative renal disease including GFR less than 50 cc/min/1.73m2 Emergency surgery Patients with preoperative hemoglobin less than 10 mg/dl Presence of chronic inflammatory diseases such as rheumatoid arthritis, malignancy, psoriasis Presence of autoimmune diseases or use of drugs that weaken the immune system Consumption of vitamins or nutritional supplements in the preoperative period

Design outcomes

Primary

MeasureTime frame
Primary Outcome: Oxidant Antioxidant Balance (PAB) Level. Timepoint: Before the start of surgery (prior to skin incision), after weaning from the cardiopulmonary bypass (CPB) and completion of the surgery. Method of measurement: the intensity of the color produced by the reaction between 3,3',5,5'-tetramethylbenzidine (TMB) and oxidant/antioxidant agents is measured using an ELISA reader at a wavelength of 450 nm. PAB values will be calculated based on a standard curve and reported in arbitrary units (HK units: Hamidi-Koliakos units).

Secondary

MeasureTime frame
Mechanical Ventilation Duration. Timepoint: From ICU admission until the end of mechanical ventilation. Method of measurement: Duration in hours recorded by the ventilator’s internal timer and corroborated with nursing charts.;ICU Length of Stay. Timepoint: From ICU admission to discharge from ICU. Method of measurement: Number of days between ICU admission and discharge times, as documented in the medical record.;Hemoglobin Level. Timepoint: At T0 (preoperative), T1 (ICU admission), and T2(24 hours post-ICU). Method of measurement: : Measured by an automated hematology analyzer.;Hematocrit Level. Timepoint: At T0 (preoperative), T1 (ICU admission), and T2(24 hours post-ICU). Method of measurement: Determined by an automated hematology analyzer.;Serum Osmolarity. Timepoint: Befor CPB , After CPB , 24 hours post-ICU. Method of measurement: Measured on a freezing-point depression osmometer.;Serum Glucose Level. Timepoint: At T0 (preoperative), T1 (ICU admission), and T2(24 hours post-ICU). Method of measurement: Enzymatic colorimetric assay (glucose oxidase/peroxidase) on a clinical chemistry analyzer.;Blood Urea Nitrogen (BUN). Timepoint: At T0 (preoperative), T1 (ICU admission), and T2(24 hours post-ICU). Method of measurement: Enzymatic BUN assay (urease-GLDH) on a chemistry analyzer.;Serum Sodium Level. Timepoint: At T0 (preoperative), T1 (ICU admission), and T2(24 hours post-ICU). Method of measurement: Measured by ion-selective electrode (ISE) method.;Serum Creatinine Level. Timepoint: At T0 (preoperative), T1 (ICU admission), and T2(24 hours post-ICU). Method of measurement: Measured by Jaffe picric acid colorimetric method or enzymatic assay on a chemistry analyzer.;Glomerular Filtration Rate (GFR). Timepoint: At T0 (preoperative), T1 (ICU admission), and T2(24 hours post-ICU).and T3 (48 hours post-ICU). Method of measurement: Calculated using the CKD-EPI equation based on serum creatinine, age, and sex.;Liver Function Tests (AST, ALT, ALP, Total & Direct Bil

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Asghar Moinpour

Mashhad University of Medical Sciences

Ahmadih4012@mums.ac.ir09805132737011

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026