Histamine Release and Implications of H1- and H2-Blockade in Adult Cardiac Surgery - A Randomised Controlled Study
| ISRCTN | ISRCTN28343638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28343638 |
| Protocol serial number | N/A |
| Sponsor | University of Wales College of Medicine, UK |
| Funder | University of Wales College of Medicine (UWCM) Endowment Fund, UK |
- Submission date
- 15/12/2004
- Registration date
- 31/01/2005
- Last edited
- 02/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Cristina Diaz-Navarro
Scientific
Scientific
University Hospital of Wales
Cardiff
CF4 4XW
United Kingdom
| Phone | +44 (0)2920743107 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | H1 and H2 blockers |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | Entry criteria: Patients presenting for elective coronary artery bypass grafting (CABG) and valve surgeries using cardiopulmonary bypass. |
| Key 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 |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
University Hospital of Wales
Cardiff
CF4 4XW
United Kingdom
CF4 4XW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
