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ISRCTN
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ISRCTN09881876
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ClinicalTrials.gov identifier
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Public title
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Optimal timing for Angiotensin Converting Enzyme (ACE) Inhibitor discontinuation in patients undergoing cardiac surgery on cardiopulmonary bypass.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0436130524
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Cardiovascular
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Participants - inclusion criteria
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Patients undergoing elective first time coronary artery surgery on the ACE inhibitor Ramipril will be eligible for the study.
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Participants - exclusion criteria
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Exclusion criteria are redo procedures and poor left ventricular function (Ejection Fraction <30%).
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Anticipated start date
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01/06/2003
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Anticipated end date
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01/02/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Patients will be randomised to discontinuing their ACE inhibitor 7 days preoperatively or continuing the medication until the morning of operation.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Leeds Teaching Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
A A A
Ali
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Address
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Department of Cardiothoracic Surgery
Yorkshire Heart Centre
Leeds General Infirmary
Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Tel
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+44 (0)7967 672729
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Fax
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+44 (0)113 392 5408
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Email
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r&d@leedsth.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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21/12/2009
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Date ISRCTN assigned
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30/09/2004
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