Benefits of Phosphocreatine use during Tetralogy of Fallot repair in children

Effectiveness of Phosphocreatine in myocardial protection during intracardiac repair for Tetralogy of Fallot: a randomised control trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011594

Enrollment

Registered

2018-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Children with Tetralogy of Fallot aged 6 months to 14 years undergoing intracardiac repair

Interventions

Intervention1: phosphocreatine is added to the cardioplegia solution in half the participants: phosphocreatine is added to the cardioplegia at a concentration of 10mmol/l. the functional outcome is me

Eligibility

Inclusion criteria

Inclusion criteria: all cases undergoing intracardiac repair for TOF

Exclusion criteria

Exclusion criteria: 1. Emergency cases 2. TOF with Absent pulmonary valve

Design outcomes

Primary

Measure	Time frame
1. Change in RV function as assessed on echocardiography a) TAPSE b) FAC 2. Serum CK-MB, TnT levelsTimepoint: 1. 2D ECHO pre CPB(cardiac bypass), post CPB, at the end of 24hrs, before discharge from ICU and at the end of 3 months post surgery ( Parameters include TAPSE, MPI, Sâ??, FAC, Tricuspid E/A, E/Eâ?? ratio) 2. Serum CK-MB levels from Postoperative day 1 to 5 3. Serum TnT levels from Postoperative day 1 to 5	—

Measure

Time frame

1. Change in RV function as assessed on echocardiography a) TAPSE b) FAC 2. Serum CK-MB, TnT levelsTimepoint: 1. 2D ECHO pre CPB(cardiac bypass), post CPB, at the end of 24hrs, before discharge from ICU and at the end of 3 months post surgery ( Parameters include TAPSE, MPI, Sâ??, FAC, Tricuspid E/A, E/Eâ?? ratio) 2. Serum CK-MB levels from Postoperative day 1 to 5 3. Serum TnT levels from Postoperative day 1 to 5

—

Secondary

Measure	Time frame
1. Other echocardiographic parameters of RV to be assessed include -MPI, Sâ??, Tricuspid E/A ratio, E/Eâ?? ratio. 2. Duration of inotropic support, inotropic score and vasoactive inotropic score (VIS) 3. Incidence of perioperative arrhythmias 4. Number of DC shocks required to restore sinus rhythm, if anyTimepoint: 1. 2D ECHO pre CPB, post CPB, at the end of 24hrs, before discharge from ICU and at the end of 3 months post surgery ( Parameters include TAPSE, MPI, Sâ??, FAC, Tricuspid E/A, E/Eâ?? ratio) 2,3. duration of stay in the ICU 4. intraoperatively	—

Measure

Time frame

1. Other echocardiographic parameters of RV to be assessed include -MPI, Sâ??, Tricuspid E/A ratio, E/Eâ?? ratio. 2. Duration of inotropic support, inotropic score and vasoactive inotropic score (VIS) 3. Incidence of perioperative arrhythmias 4. Number of DC shocks required to restore sinus rhythm, if anyTimepoint: 1. 2D ECHO pre CPB, post CPB, at the end of 24hrs, before discharge from ICU and at the end of 3 months post surgery ( Parameters include TAPSE, MPI, Sâ??, FAC, Tricuspid E/A, E/Eâ?? ratio) 2,3. duration of stay in the ICU 4. intraoperatively

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Countries

India

Contacts

Public ContactG Keerthi

PGIMER

baryah@hotmail.com7087009554

Outcome results

None listed

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