Comparison of the effects of Del Nido and Custodiol cardioplegia have on peri-operation events in patients with Tetralogy of Fallot

Comparative study of the effect of Del Nido and Custodiol cardioplegia on peri-operation clinical outcomes in patients with Tetralogy of Fallot who undergoing cardiopulmonary bypass

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190520043649N1

Enrollment

Registered

2020-06-27

Start date

2018-05-19

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

Tetralogy of Fallot.

Interventions

Intervention 1: Control group: Del Nido cardioplegia base solution is a liter of plasmalyte-A solution that is similar to extracellular fluid. Its basic composition includes:140 mEq/L sodium, 5 mEq/L

Eligibility

Sex/Gender

All

Age

6 Months to 24 Months

Inclusion criteria

Inclusion criteria: Children with TOF anatomy who undergoing cardiopulmonary bypass aged 6 to 24 months Cross-clamp time between 60 and 120 minutes Obtain informed consent from parents

Exclusion criteria

Exclusion criteria: redo cardiac surgery intubated

Design outcomes

Primary

Measure	Time frame
Coronary sinus lactate. Timepoint: At the opening of aorta clamp. Method of measurement: Take the blood sample and using laboratory kits.;Troponin I. Timepoint: Before surgery, intensive care unit entrance, 24 hours after intensive care unit entrance. Method of measurement: Take the blood sample and use the laboratory kits.;Ejection fraction. Timepoint: Preoperative, postoperative, discharge time. Method of measurement: Echo.;General lactate of the body. Timepoint: Before surgery, during surgery, 6 hours after surgery, 12 hours after surgery, 18 hours after surgery, 24 hours after surgery. Method of measurement: Take the blood sample and use the laboratory kits.	—

Measure

Time frame

Coronary sinus lactate. Timepoint: At the opening of aorta clamp. Method of measurement: Take the blood sample and using laboratory kits.;Troponin I. Timepoint: Before surgery, intensive care unit entrance, 24 hours after intensive care unit entrance. Method of measurement: Take the blood sample and use the laboratory kits.;Ejection fraction. Timepoint: Preoperative, postoperative, discharge time. Method of measurement: Echo.;General lactate of the body. Timepoint: Before surgery, during surgery, 6 hours after surgery, 12 hours after surgery, 18 hours after surgery, 24 hours after surgery. Method of measurement: Take the blood sample and use the laboratory kits.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeid Heidarynia

Shahid Rajaie Heart Center

saeid68520@gmail.com+98 21 23921

Outcome results

None listed

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