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Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

N

NHS Greater Glasgow Yorkhill Division

Status and phase

Unknown
Phase 4

Conditions

Cardiopulmonary Bypass

Treatments

Drug: Sildenafil Citrate

Study type

Interventional

Funder types

Other

Identifiers

NCT00350441
05/CA/01

Details and patient eligibility

About

Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury associated with cardiopulmonary bypass in children undergoing corrective surgical repair of congenital heart disease.

Sex

All

Ages

3 months to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Paediatric patients undergoing open heart surgery utilising cardiopulmonary bypass to correct acyanotic congenital heart disease.

Age > 3 months Parents that show a good understanding of their child's condition and are happy for their child to participate in the study.

Exclusion criteria

Patients with known organ dysfunction prior to surgery (pulmonary, renal or hepatic) Communication barrier resulting in poor basic comprehension of the proposed study (e.g. language barrier) Patients with cyanotic heart disease Patients undergoing heart surgery without the use of cardiopulmonary bypass Patients who do not tolerate oral Sildenafil (e.g. Vomiting) or whose surgery is subsequently cancelled.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Tony Vassalos, MB Ch B

Data sourced from clinicaltrials.gov

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