The perioperative outcome of inhaled and intravenous levosimendan in children with pulmonary hypertension undergoing on pump cardiac surgery: a comparative randomized study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR201911571076749

Enrollment

Registered

2019-11-18

Start date

2019-12-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Paediatrics Anaesthesia

Interventions

patients will not receive levosimendan. The patients will receive normal saline by inhalation

Intravenous Group

Inhalation Group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1-Age from 1 to 10 years 2-on pump elective correction of congenital heart diseases 3- pulmonary arterial hypertension

Exclusion criteria

Exclusion criteria: 1-refusal of the patients guardians 2- contraindication to use TEE 3-redo cardiac surgery 4-coagulation disorders 5-renal, hepatic or pulmonary disease 6-heart failure, Eisenmenger syndrome or right to left shunts and hypersensitivity of any of the studied drugs.

Design outcomes

Primary

Measure	Time frame
assessment of intra and post-operative systolic PAP	—

Secondary

Measure	Time frame
1. Heart rate(Hr) 2. Mean arterial pressure (MAP). 3. Central venous pressure (CVP). 4. Stroke volume (SV) using TEE 5. Cardiac output (CO) using TEE. 6. Ejection fraction (EF) using TEE. 7. Fraction shortening (FS) using TEE. 8. Respiratory parameters (SPO2, PaO2 and PaCO2). 9. Vasopressors (epinephrine and norepinephrine). 10. Urine output 11. Fluid and blood requirements intra and postoperative. 12. Time to wean from mechanical ventilation. 13. Duration of ICU stay 14. Time of hospital stay	—

Measure

Time frame

1. Heart rate(Hr) 2. Mean arterial pressure (MAP). 3. Central venous pressure (CVP). 4. Stroke volume (SV) using TEE 5. Cardiac output (CO) using TEE. 6. Ejection fraction (EF) using TEE. 7. Fraction shortening (FS) using TEE. 8. Respiratory parameters (SPO2, PaO2 and PaCO2). 9. Vasopressors (epinephrine and norepinephrine). 10. Urine output 11. Fluid and blood requirements intra and postoperative. 12. Time to wean from mechanical ventilation. 13. Duration of ICU stay 14. Time of hospital stay

—

Countries

Egypt

Contacts

Public ContactNabil Abd Elraouf

Professor of anesthesia and surgical Intensive care

nabil_abdelraouf@yahoo.com+20100491538648

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026