NCT00350441

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
Last Updated

October 11, 2006

Status Verified

July 1, 2006

First QC Date

July 7, 2006

Last Update Submit

October 10, 2006

Conditions

Cardiopulmonary Bypass

Keywords

Sildenafil CitrateCardiopulmonary bypassOpen heart surgery

Interventions

Sildenafil CitrateDRUG

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hospital for Sick Children

Glasgow, Strathclyde, G3 8SJ, United Kingdom

RECRUITING

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tony Vassalos, MB Ch B

    Royal Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Vassalos, MB Ch B

CONTACT

0141 201 1000tonyv@doctors.org.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

June 1, 2006

Last Updated

October 11, 2006

Record last verified: 2006-07

Locations

GB(1)