Contact information
Type
Scientific
Primary contact
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 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
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
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
Phase
Not Specified
Drug names
Angiotensin Converting Enzyme (ACE) Inhibitor
Primary outcome measures
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 trial start date
01/06/2003
Overall trial end date
01/02/2006
Reason abandoned
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
Patient
Age group
Not Specified
Gender
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
United Kingdom
Trial 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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary