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Trial registered on ANZCTR


Registration number
ACTRN12617001365358
Ethics application status
Approved
Date submitted
18/09/2017
Date registered
27/09/2017
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized clinical trial comparing preoperative continuation versus cessation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in patients undergoing elective, noncardiac surgery at a major tertiary hospital.
Scientific title
A randomized clinical trial comparing preoperative continuation versus cessation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in patients undergoing elective, noncardiac surgery at a major tertiary hospital.
Secondary ID [1] 292915 0
Nil known
Universal Trial Number (UTN)
U1111-1202-2693
Trial acronym
PAAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
noncardiac surgery 304776 0
perioperative cardiovascular events 304777 0
cardiovascular mortality 304778 0
cardiac arrest
304779 0
decompensated cardiac failure
304780 0
myocardial infarction 304781 0
myocardial injury after noncardiac surgery 304782 0
acute kidney injury 304783 0
cerebrovascular event 304784 0
Condition category
Condition code
Anaesthesiology 304090 304090 0 0
Other anaesthesiology
Cardiovascular 304091 304091 0 0
Other cardiovascular diseases
Surgery 304092 304092 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Withholding angiotensin converting enzyme II inhibitors (ACEi) and angiotensin receptor blockers (ARBs) medication at least twenty-four hours prior to noncardiac surgery. The commencement of ACEi and ARB after surgery will be independent of the clinical trial and at the discretion of the treating clinician.
Intervention code [1] 299147 0
Treatment: Drugs
Comparator / control treatment
Continuing angiotensin converting enzyme II inhibitors (ACEi) and angiotensin receptor blockers (ARBs) medication prior to noncardiac surgery
Control group
Active

Outcomes
Primary outcome [1] 303408 0
Composite outcome of cardiovascular mortality, cardiac arrest, cardiac arrhythmia, decompensated cardiac failure, stroke, and myocardial infarction in the period from anesthesia induction to five days post-operatively. The outcome will be assessed by reviewing medical records and investigations. All outcome events will be assessed by an independent adjudicator.
Timepoint [1] 303408 0
Five days postoperatively
Secondary outcome [1] 338857 0
all-cause mortality
Timepoint [1] 338857 0
30-day
Secondary outcome [2] 338858 0
cardiovascular mortality
- as per ICD-10 coding for cause of death with I00-I99 representing cardiovascular mortality
- all outcome events with be reviewed by an independent adjudicator
Timepoint [2] 338858 0
30-day
Secondary outcome [3] 338859 0
Myocardial injury after noncardiac surgery (MINS)
- as defined by peak cTnT >= 0.03ng/ml without evidence of non-ischaemic etiology
Timepoint [3] 338859 0
three days
Secondary outcome [4] 338860 0
Postoperative acute kidney injury
- using AKIN definition of AKI as follows: creatinine: >1.5 times baseline OR > 26.5 mmol/l increase OR urine output: <0.5 ml/kg/h for 6–12 hours as measured using an indwelling catheter (IDC)
Timepoint [4] 338860 0
five days
Secondary outcome [5] 338861 0
Composite outcome of clinical significant haemodynamic instability during operation or up to five days.
Consists of the following
o Intraoperative hypotension: Mean arterial blood pressure <65mmHg
o Postoperative hypotension: Systolic blood pressure < 90 mmHg requiring intervention (fluid administration, vasopressor use
o Postoperative hypertension: Systolic blood pressure >180mmHg requiring immediate administration of antihypertensive medication
Timepoint [5] 338861 0
Five days

Eligibility
Key inclusion criteria
• Adult (>18 years of age)
• Non-pregnant
• Patients at Princess Alexandra Hospital (Brisbane, Queensland)
• Attendance at preadmission clinic at least twenty-four hours prior to day of surgery
• Elective surgery
• Planned general anaesthetic
• Prescribed an ACEi or ARB on a stable dose for the previous twenty-eight days
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Systolic blood pressure greater than 180 mmHg noted on preadmission clinic visit
• Cardiac surgery
• Transplant surgery
• Cognitive impairment or other neurological disorders resulting in patients lacking capacity to provide informed consent and a legally authorized substitute decision maker (power of attorney or statutory health attorney or appointed guardian) does not exist or is unavailable to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Online / Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
To compare the risk of postoperative cardiovascular events between the group of patients withholding AAB agents at least twenty-fours prior to noncardiac surgery and the ones continuing these agents, a Chi-square test or Fisher’s exact test (when appropriate) will be performed.

The association between treatment group and perioperative mortality, myocardial events, postoperative acute kidney injury, postoperative stroke and clinically significant haemodynamic instability will be investigated using Chi-square test or Fisher’s exact test (when appropriate) for categorical outcomes and t-test or Mann-Whitney test (when appropriate) for continuous outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9044 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 17527 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297545 0
Self funded/Unfunded
Name [1] 297545 0
Not applicable
Address [1] 297545 0
Not applicable
Country [1] 297545 0
Primary sponsor type
Hospital
Name
Metro South Health - Princess Alexandra Hospital
Address
199 Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 296553 0
None
Name [1] 296553 0
Not applicable
Address [1] 296553 0
Not applicable
Country [1] 296553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298640 0
Metro South Health HREC
Ethics committee address [1] 298640 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 298640 0
Australia
Date submitted for ethics approval [1] 298640 0
13/07/2017
Approval date [1] 298640 0
25/08/2017
Ethics approval number [1] 298640 0
HREC/17/QPAH/476

Summary
Brief summary
The research study will investigate the effect a common blood pressure tablet has on patients undergoing elective surgery. Participants will be randomly assigned to continue or cease their angiotensin converting enzyme inhibitors and angiotensin receptor blockers at least one day before their operation. Researchers will collate and analyze routinely collected patient information to detect if continuation or cessation results in better outcomes for the participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77742 0
A/Prof Ian Scott
Address 77742 0
Internal Medicine Department
Princess Alexandra Hospital
199 Ipswich Road Woolloongabba, QLD 4102

Country 77742 0
New Zealand
Phone 77742 0
+61731767355
Fax 77742 0
Email 77742 0
ian.scott@health.qld.gov.au
Contact person for public queries
Name 77743 0
A/Prof Ian Scott
Address 77743 0
Internal Medicine Department
Princess Alexandra Hospital
199 Ipswich Road Woolloongabba, QLD 4102
Country 77743 0
Australia
Phone 77743 0
+61731767355
Fax 77743 0
Email 77743 0
ian.scott@health.qld.gov.au
Contact person for scientific queries
Name 77744 0
A/Prof Ian Scott
Address 77744 0
Internal Medicine Department
Princess Alexandra Hospital
199 Ipswich Road Woolloongabba, QLD 4102
Country 77744 0
Australia
Phone 77744 0
+61731767355
Fax 77744 0
Email 77744 0
ian.scott@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Currently undecided
What supporting documents are/will be available?
No other documents available
Summary results
No Results