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Evaluating treatment to decrease pleural effusion in patients undergoing Fontan heart surgery

ORAL SILDENAFIL ADMINISTRATION IN PATIENTS UNDERGOING EXTRACARDIAC FONTAN PROCEDURE - A DOUBLE BLIND RANDOMIZED STUDY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009927
Enrollment
90
Registered
2017-09-26
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- Univentricular physiology

Interventions

Intervention1: Sildenafil: In the immediate post-op, tab sildenafil will be given at the dose of 0.5 mg/kg/dose thrice daily through nasogastric tube till orally allowed and then orally for the durati

Sponsors

Director AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with univentricular physiology with age > 4 years. 2. Fit to undergo Extracardiac fontan procedure.

Exclusion criteria

Exclusion criteria: 1. Patients with univentricular physiology whose age 2. Parents/guardians not willing to give consent to participate in this study.

Design outcomes

Primary

MeasureTime frame
Duration and amount of pleural drainage following Fontan procedure in patients on sildenafil compared to placeboTimepoint: 1 month following fontan surgery

Secondary

MeasureTime frame
Hospital stay, time to removal of chest tubes, readmissions and reinsertions of chest tube within 1 month following Fontan procedure in patients on sildenafil compared to placeboTimepoint: Hospital stay, time to removal of chest tubes, readmissions and reinsertions of chest tube within 1 month following Fontan procedure in patients on sildenafil compared to placebo

Countries

India

Contacts

Public ContactDr Bharath V

All India Institute of Medical Sciences, New Delhi

sachintalwar@hotmail.com9868398136

Outcome results

None listed

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