Condition category
Circulatory System
Date applied
15/12/2004
Date assigned
31/01/2005
Last edited
02/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cristina Diaz-Navarro

ORCID ID

Contact details

University Hospital of Wales
Cardiff
CF4 4XW
United Kingdom
+44 (0)2920743107

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Systemic inflammatory response is associated with cardiac surgery. Mediators liberated include cytokines and histamine. Histamine is associated with systemic effects like vasodilatation and cardiac dysrhythmias.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular disease

Intervention

Patients will be randomly allocated into two groups.
Group H: this group will receive prophylactic H1- and H2-blockade
Group O: control group with no H1- and H2-blockade (placebo)
The study will be double blinded.

Intervention type

Drug

Phase

Not Specified

Drug names

H1 and H2 blockers

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Entry criteria: Patients presenting for elective coronary artery bypass grafting (CABG) and valve surgeries using cardiopulmonary bypass.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Patients on heparin or nitrate infusions
2. Patients with known allergies
3. Known asthmatics and patients with severe chronic obstructive pulmonary disease (COPD)
4. Patients on steroids or other immunosuppressive drugs
5. Emergency procedures or re-do operations
6. Patients on regular H1 or H2 blockers

Recruitment start date

01/02/2005

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of Wales
Cardiff
CF4 4XW
United Kingdom

Sponsor information

Organisation

University of Wales College of Medicine, UK

Sponsor details

Heath Park
Cardiff
CF4 4XW
United Kingdom
HumphreysJM@cf.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Wales College of Medicine (UWCM) Endowment Fund, UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes