Comparison of clinical outcomes of two different types of cardioplegia solutions in cardiac surgery patients

A comparative study of clinical outcomes of two different types of cardioplegia solutions in patients undergoing coronary artery bypass graft surgery.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200825048515N80

Enrollment

Registered

2025-02-19

Start date

2025-02-19

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 bypass surgery. Atherosclerosis of coronary artery bypass graft(s) without angina pectoris

Interventions

Intervention 1: Intervention group: In this group, a manual cardioplegia solution is used, which is prepared by adding 40 meq of potassium chloride (20 ml of 15% KCl), 1 g of magnesium sulfate, 50 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Candidate for elective CABG surgery with CPB No arrhythmia before surgery EF above 30% Consent to participate in the study

Exclusion criteria

Exclusion criteria: Potassium level in the critical range before surgery Magnesium level in the critical range before surgery Severe aortic insufficiency and left main coronary stenosis before surgery Concomitant need for aortic valve replacement or aortic root repair and ascending aortic manipulation

Design outcomes

Primary

Measure	Time frame
Potassium level. Timepoint: Before surgery, before starting CPB and 10 minutes after administering the first dose of cardioplegia and 5 minutes after removing the aortic clamp, 6, 12, and 24 hours after surgery. Method of measurement: Blood test.;Magnesium level. Timepoint: Before surgery, before starting CPB and 10 minutes after administering the first dose of cardioplegia and 5 minutes after removing the aortic clamp, 6, 12, and 24 hours after surgery. Method of measurement: Blood test.;Lactate dehydrogenase(LDH). Timepoint: Before surgery, 12, and 24 hours after surgery. Method of measurement: Blood test.;C-Reactive Protein. Timepoint: Before surgery, 12, and 24 hours after surgery. Method of measurement: Blood test.;Troponin I. Timepoint: Before surgery, 12, and 24 hours after surgery. Method of measurement: Blood test.	—

Measure

Time frame

Potassium level. Timepoint: Before surgery, before starting CPB and 10 minutes after administering the first dose of cardioplegia and 5 minutes after removing the aortic clamp, 6, 12, and 24 hours after surgery. Method of measurement: Blood test.;Magnesium level. Timepoint: Before surgery, before starting CPB and 10 minutes after administering the first dose of cardioplegia and 5 minutes after removing the aortic clamp, 6, 12, and 24 hours after surgery. Method of measurement: Blood test.;Lactate dehydrogenase(LDH). Timepoint: Before surgery, 12, and 24 hours after surgery. Method of measurement: Blood test.;C-Reactive Protein. Timepoint: Before surgery, 12, and 24 hours after surgery. Method of measurement: Blood test.;Troponin I. Timepoint: Before surgery, 12, and 24 hours after surgery. Method of measurement: Blood test.

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Secondary

Measure	Time frame
Inotrope requirement. Timepoint: Within 24 hours after surgery. Method of measurement: Calculation of the prescribed dose.;Occurrence of ventricular arrhythmias. Timepoint: After Clamp. Method of measurement: Observation of arrhythmia occurrence.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Hosseini

Esfahan University of Medical Sciences

drhosseiny@yahoo.com+98 31 3260 0961

Outcome results

None listed

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