Contact information
Type
Scientific
Contact name
Mr A A A Ali
ORCID ID
Contact details
Department of Cardiothoracic Surgery
Yorkshire Heart Centre
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)7967 672729
r&d@leedsth.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0436130524
Study information
Scientific title
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
01/02/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing elective first time coronary artery surgery on the ACE inhibitor Ramipril will be eligible for the study.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Exclusion criteria are redo procedures and poor left ventricular function (Ejection Fraction <30%).
Recruitment start date
01/06/2003
Recruitment end date
01/02/2006
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Department of Cardiothoracic Surgery
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|