Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes