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Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

NCT ID: NCT00350441

Last Updated: 2006-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiopulmonary Bypass

Keywords

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Sildenafil Citrate Cardiopulmonary bypass Open heart surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sildenafil Citrate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow Yorkhill Division

OTHER

Sponsor Role lead

Principal Investigators

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Tony Vassalos, MB Ch B

Role: PRINCIPAL_INVESTIGATOR

Royal Hospital for Sick Children

Locations

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Royal Hospital for Sick Children

Glasgow, Strathclyde, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Tony Vassalos, MB Ch B

Role: CONTACT

Phone: 0141 201 1000

Email: [email protected]

Facility Contacts

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Tony Vassalos

Role: primary

Mark Danton

Role: backup

Other Identifiers

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05/CA/01

Identifier Type: -

Identifier Source: org_study_id