Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by NHS Greater Glasgow Yorkhill Division.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NHS Greater Glasgow Yorkhill Division
ClinicalTrials.gov Identifier:
NCT00350441
First received: July 7, 2006
Last updated: October 10, 2006
Last verified: July 2006
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00350441     History of Changes
Other Study ID Numbers: 05/CA/01
Study First Received: July 7, 2006
Last Updated: October 10, 2006
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

Additional relevant MeSH terms:
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 18, 2014