Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

This study is currently recruiting participants.

Verified by NHS Greater Glasgow Yorkhill Division, July 2006

Sponsored by:	NHS Greater Glasgow Yorkhill Division
Information provided by:	NHS Greater Glasgow Yorkhill Division
ClinicalTrials.gov Identifier:	NCT00350441

Purpose

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.

Condition	Intervention	Phase
Cardiopulmonary Bypass	Drug: Sildenafil Citrate	Phase IV

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
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.

Further study details as provided by NHS Greater Glasgow Yorkhill Division:

Estimated Enrollment:	12
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	3 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350441

Contacts

Contact: Tony Vassalos, MB Ch B

0141 201 1000

tonyv@doctors.org.uk

Locations

United Kingdom, Strathclyde
Royal Hospital for Sick Children	Recruiting
Glasgow, Strathclyde, United Kingdom, G3 8SJ
Contact: Tony Vassalos 0141 201 1000 tonyv@doctors.org.uk
Contact: Mark Danton 0141 201 1000 mark.danton@yorkhill.scot.nhs.uk
Principal Investigator: Tony Vassalos

Sponsors and Collaborators

NHS Greater Glasgow Yorkhill Division

Investigators

Principal Investigator:

Tony Vassalos, MB Ch B

Royal Hospital for Sick Children

More Information

Study ID Numbers:	05/CA/01
Study First Received:	July 7, 2006
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00350441
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Glasgow Yorkhill Division:

Sildenafil Citrate
Cardiopulmonary bypass
Open heart surgery

Study placed in the following topic categories:

Citric Acid
Sildenafil

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009