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 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | H1 and H2 blockers |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2005 |
| Overall study end date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 80 |
| Participant inclusion criteria | Entry criteria: Patients presenting for elective coronary artery bypass grafting (CABG) and valve surgeries using cardiopulmonary bypass. |
| 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
- Wales
Study participating centre
University Hospital of Wales
Cardiff
CF4 4XW
United Kingdom
CF4 4XW
United Kingdom
Sponsor information
University of Wales College of Medicine, UK
University/education
University/education
Heath Park
Cardiff
CF4 4XW
Wales
United Kingdom
| HumphreysJM@cf.ac.uk | |
"ROR" |
https://ror.org/01se4f844 |
Funders
Funder type
University/education
University of Wales College of Medicine (UWCM) Endowment Fund, UK
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
