Skip to content

The Effect of Del Nido Cardioplegia Solution Containing selenium on Perioperative Clinical Outcomes and Laboratory Criteria of CABG Patients

Comparative study of the effect of selenium-containing and selenium-free Del Nido cardioplegia solution administration on clinical outcomes and laboratory parameters in patients undergoing coronary artery bypass graft surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241110063657N1
Enrollment
60
Registered
2025-02-03
Start date
2024-12-04
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

Patients undergoing coronary artery bypass surgery. Atherosclerotic heart disease of native coronary artery

Interventions

Intervention 1: Intervention group: In the intervention group, 500 micrograms of selenium will be injected in the Del Nido Cardioplegia solution. During surgery, moderate hypothermia (32-34°C) will be

Sponsors

Rajaee heart center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1- The patient's willingness to participate in the study Informed consent to participate in the study 3- Age 18 to 75 years old 4- Left ventricular ejection fraction greater than 30% 5- No history of sternotomy and previous cardiac surgeries 5- No history of liver disease, kidney, lung 6- not having valvular problems that require surgery at the same time as coronary arteries 7- not having a pacemaker 8- not being pregnant 9- not having a history of allergy to Selenium 10 - not having G6PD disease -

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1- pump time more than 120 minutes 2- cross-clamp more than 100 minutes 3- performing ultrafiltration technique 4- return of the patient to the cardiopulmonary machine for any reason during

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction. Timepoint: Before operation, after operation and during discharge in control group and selenium group in CABG patients undergoing cardiopulmonary bypass. Method of measurement: Information collection form.;Hemodynamic parameters (vital signs, time to reach the first reversible rhythm, first reversible rhythm, need for inotrope, use of shock or pacemaker, etc.) and arterial blood gas parameters (arterial blood oxygen, pao2, paco2. Timepoint: before induction of anesthesia, after cardioplegia injection, during rewarming, after the end of cardiopulmonary bypass, when entering the ICU, 12 and 24 hours after the operation in the control group and the selenium group in CABG patients undergoing cardiopulmonary bypass. Method of measurement: Data collection form - blood sample.;Biomarkers of myocardial damage (CK-MB, Troponin I. Timepoint: Before the operation, upon entering the ICU and 24 hours after the operation in the control group and the selenium group in CABG patients undergoing cardiopulmonary bypass. Method of measurement: blood sample.

Secondary

MeasureTime frame
Duration of intubation. Timepoint: Post operative. Method of measurement: patients file.;Length of stay in the intensive care unit. Timepoint: Post operative. Method of measurement: patients file.;Length of stay in the hospital. Timepoint: Post operative. Method of measurement: patients file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Mohammadghasemi

Rajaee heart center

pari.perfusion@gmail.com+98 21 23921

Outcome results

None listed

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