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

Phase 1

• Conditions: Anaesthesia; Paediatrics

• Registration Number: PACTR201911571076749
• Lead Sponsor: Mansoura university children hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assessment of intra and post-operative systolic PAP

Secondary Outcome Measures

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