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NCT00350441 Clinical Trial

Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

Cardiopulmonary Bypass Clinical Trial

Official title:
A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study of the Pre-Operative Effect of Sildenafil Citrate on Pulmonary Related Complications Following Cardiopulmonary Bypass in Children Undergoing Cardiac Surgical Repair.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00350441
Other study ID # 05/CA/01
Secondary ID
Status Recruiting
Phase Phase 4
First received July 7, 2006
Last updated October 10, 2006
Start date June 2006

Study information
Verified date July 2006
Source NHS Greater Glasgow Yorkhill Division
Contact Tony Vassalos, MB Ch B
Phone 0141 201 1000
Email tonyv@doctors.org.uk
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 5 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil Citrate

Locations
Country Name City State
United Kingdom Royal Hospital for Sick Children Glasgow Strathclyde

Sponsors (1)
Lead Sponsor Collaborator
NHS Greater Glasgow Yorkhill Division

Country where clinical trial is conducted

United Kingdom, 

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