Optimal timing for Angiotensin Converting Enzyme (ACE) Inhibitor discontinuation in patients undergoing cardiac surgery on cardiopulmonary bypass.
| ISRCTN | ISRCTN09881876 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09881876 |
| Secondary identifying numbers | N0436130524 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 29/08/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Mr A A A Ali
Scientific
Scientific
Department of Cardiothoracic Surgery
Yorkshire Heart Centre
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)7967 672729 |
|---|---|
| r&d@leedsth.nhs.uk |
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 objectives | There is some evidence that the continuation of ACE inhibitors until the time of surgery may lead to increased requirements of vasoconstrictor agents to maintain blood pressure. We aim to investigate this suggestion. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Cardiovascular |
| Intervention | Patients will be randomised to discontinuing their ACE inhibitor 7 days preoperatively or continuing the medication until the morning of operation. 29/08/2012: Please note that this trial was abandoned before starting. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Angiotensin Converting Enzyme (ACE) Inhibitor |
| Primary outcome measure | Primary outcome measures are those relating to the presence and treatment of perioperative and postoperative hypotension. Systemic vascular resistance will be measured via Swan-Ganz catheterisation preoperatively and at fixed intervals in the postoperative period. In addition the requirement of vasoconstrictor agents as well as the duration of their use and the total dose administered will be documented. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2003 |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients undergoing elective first time coronary artery surgery on the ACE inhibitor Ramipril will be eligible for the study. |
| Key exclusion criteria | Exclusion criteria are redo procedures and poor left ventricular function (Ejection Fraction <30%). |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiothoracic Surgery
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (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 |
