- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350441
Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?
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.
Study Overview
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Tony Vassalos, MB Ch B
- Phone Number: 0141 201 1000
- Email: tonyv@doctors.org.uk
Study Locations
-
-
Strathclyde
-
Glasgow, Strathclyde, United Kingdom, G3 8SJ
- Recruiting
- Royal Hospital for Sick Children
-
Contact:
- Tony Vassalos
- Phone Number: 0141 201 1000
- Email: tonyv@doctors.org.uk
-
Contact:
- Mark Danton
- Phone Number: 0141 201 1000
- Email: mark.danton@yorkhill.scot.nhs.uk
-
Principal Investigator:
- Tony Vassalos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Investigators
- Principal Investigator: Tony Vassalos, MB Ch B, Royal Hospital for Sick Children
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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