Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

October 10, 2006 updated by: NHS Greater Glasgow Yorkhill Division

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow Yorkhill Division

Investigators

  • Principal Investigator: Tony Vassalos, MB Ch B, Royal Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Registration Dates

First Submitted

July 7, 2006

First Submitted That Met QC Criteria

July 7, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Estimate)

October 11, 2006

Last Update Submitted That Met QC Criteria

October 10, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/CA/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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