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Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by NHS Greater Glasgow Yorkhill Division.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350441
First Posted: July 10, 2006
Last Update Posted: October 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NHS Greater Glasgow Yorkhill Division
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00350441     History of Changes
Other Study ID Numbers: 05/CA/01
First Submitted: July 7, 2006
First Posted: July 10, 2006
Last Update Posted: October 11, 2006
Last Verified: July 2006

Keywords provided by NHS Greater Glasgow Yorkhill Division:
Sildenafil Citrate
Cardiopulmonary bypass
Open heart surgery

Additional relevant MeSH terms:
Citric Acid
Sildenafil Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents