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Trial registered on ANZCTR


Registration number
ACTRN12624001325594
Ethics application status
Approved
Date submitted
4/10/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Vasopressin on intra-operative blood pressure and illness after heart surgery
Scientific title
Effects of vasopressin vs placebo on postoperative complications in cardiac surgery in adults (V-PACE): a feasibility study for a randomised trial.
Secondary ID [1] 311381 0
None
Universal Trial Number (UTN)
U1111-1303-0673
Trial acronym
V-PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 332652 0
Hypotension 332653 0
Atrial fibrillation 332654 0
Acute kidney injury 332655 0
Condition category
Condition code
Anaesthesiology 329357 329357 0 0
Other anaesthesiology
Cardiovascular 329358 329358 0 0
Diseases of the vasculature and circulation including the lymphatic system
Renal and Urogenital 329359 329359 0 0
Kidney disease
Cardiovascular 329360 329360 0 0
Other cardiovascular diseases
Surgery 332090 332090 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A vasopressin infusion started at a rate of 2IU/hr (2mls/hr). The infusion will be made up as 50 IU in 50mls of 0.9% saline. The study drug will be initiated after induction of anaesthesia and prior to institution of cardiopulmonary bypass . The study drug will be continued for up to 48 hours or until ready for discharge from ICU, whichever occurs sooner. The study drug drug will be run continuously. It may be paused at any point where reduced mean arterial pressure (MAP) is desirable. It may be stopped if persistently high MAP >85mmHg is encountered. Adherence will be monitored by reviewing the electronic medical record. Specifically the anaesthetic record and ICU drug chart.

Intervention code [1] 327824 0
Treatment: Drugs
Comparator / control treatment
A normal saline infusion started at the same rate (2mls/hr). The infusion will be made up as 50mls of normal saline 0.9% only. The study drug will be initiated after induction of anaesthesia and prior to institution of cardiopulmonary bypass . The study drug will be continued for up to 48 hours or until ready for discharge from ICU, whichever occurs sooner. Once the infusion has been initiated it will be run continuously. Adherence will be monitored using the electronic medical record.
Control group
Placebo

Outcomes
Primary outcome [1] 337187 0
Duration of study drug infusion
Timepoint [1] 337187 0
48 hours postoperatively
Primary outcome [2] 337188 0
Protocol adherence
Timepoint [2] 337188 0
48 hours postoperatively
Primary outcome [3] 337189 0
Accuracy of outcome data collected from registry data vs manually collected data for the future study primary outcome. This will be assessed as a composite outcome.
Timepoint [3] 337189 0
Hospital discharge
Secondary outcome [1] 431000 0
Allocation concealment - percentage achieved in primary anaesthetist
Timepoint [1] 431000 0
24 hours postoperatively
Secondary outcome [2] 431001 0
Research co-ordinator time per patient
Timepoint [2] 431001 0
Hospital discharge
Secondary outcome [3] 440865 0
Allocation concealment- percentage achieved in first intensivist
Timepoint [3] 440865 0
24hrs post operatively

Eligibility
Key inclusion criteria
Adults 18 years and over undergoing cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, combined CABG/valve surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major aortic surgery, transplant surgery, pulmonary endarterectomy, ventricular assist device placement; Already receiving inotropic/vasopressor support; dialysis dependent; pre-existing uncontrolled hypertension; pregnant or breastfeeding women; serum Na < 130mmol/l; ICU admission prior to surgery

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer (REDCap)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be described between groups with appropriate statistical methods to estimate data precision.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26076 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41931 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 317564 0
Hospital
Name [1] 317564 0
The Alfred Hospital
Country [1] 317564 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Australian and New Zealand College of Anaesthetists Clinical Trials Network Pilot Grant.
Address
630 St Kilda Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 317739 0
None
Name [1] 317739 0
Address [1] 317739 0
Country [1] 317739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314525 0
Alfred HREC
Ethics committee address [1] 314525 0
Alfred Hospital, 55 Commercial Rd, Melbourne, VIC 3004
Ethics committee country [1] 314525 0
Australia
Date submitted for ethics approval [1] 314525 0
Approval date [1] 314525 0
13/10/2023
Ethics approval number [1] 314525 0
HREC/97259/Alfred-2023

Summary
Brief summary
More than 20,000 heart operations are carried out each year in Australia. While many patients survive the operation, many spend long periods in hospital recovering. Common complications that can occur include a rapid and irregular heart rate (atrial fibrillation) and damage to the kidneys (known as acute kidney injury). These each occur in as many as one in four patients. Preventing or reducing the severity of these complications could improve the health of patients. Previous studies have suggested that acute kidney injury or atrial fibrillation may be reduced by using a drug known as ‘vasopressin’ to preserve blood pressure during surgery. Drugs to preserve blood pressure are often needed in cardiac surgery. However, the research studies that showed that vasopressin was a superior choice to noradrenaline were small, and the largest was conducted in a hospital and group of patients with a higher rate of
complications. In this study we aim to assess whether a trial comparing vasopressin to a placebo infusion (inactive substance) is feasible in a Australian population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131886 0
Dr Tim Coulson
Address 131886 0
Department of Anaesthesiology and Perioperative Medicine, Alfred Health, 55 Commercial Rd, Melbourne VIC 3004
Country 131886 0
Australia
Phone 131886 0
+61 3 9076 3707
Fax 131886 0
Email 131886 0
[email protected]
Contact person for public queries
Name 131887 0
Tim Coulson
Address 131887 0
Department of Anaesthesiology and Perioperative Medicine, Alfred Health, 55 Commercial Rd, Melbourne VIC 3004
Country 131887 0
Australia
Phone 131887 0
+61 3 90762000
Fax 131887 0
Email 131887 0
[email protected]
Contact person for scientific queries
Name 131888 0
Tim Coulson
Address 131888 0
Department of Anaesthesiology and Perioperative Medicine, Alfred Health, 55 Commercial Rd, Melbourne VIC 3004
Country 131888 0
Australia
Phone 131888 0
+61 3 90762000
Fax 131888 0
Email 131888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of HREC approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21465Study protocol    To be published



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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