Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000838415
Ethics application status
Approved
Date submitted
10/06/2025
Date registered
5/08/2025
Date last updated
5/08/2025
Date data sharing statement initially provided
5/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The MINImum Mean Arterial Pressure in critically ill patients requiring vasopressors Trial. A phase III, randomised controlled trial. (MINI-MAP Trial)
Scientific title
The MINImum Mean Arterial Pressure in critically ill patients requiring vasopressors Trial. A phase III, randomised controlled trial.
Secondary ID [1] 314614 0
MINI-MAP Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 337752 0
Hypotension 337753 0
Shock 337754 0
Condition category
Condition code
Cardiovascular 334084 334084 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Titration of vasopressors to achieve the prescribed mean arterial pressure (MAP) target from randomisation to day 90 of ICU admission, death, or ICU discharge

Three groups of prescribed one of three minimum MAP targets, 60, 65 or 70 mmHg. The aim will be to use the lowest amount of vasopressor possible to achieve the specified target. The titration of vasopressor to the prescribed minimum MAP will be performed by the treating team including the bedside nurse, and medical staff.

The choice of vasopressor is up to the treating clinician. Examples of vasopressors will be noradrenaline, vasopressin, metaraminol, phenylephrine, adrenaline, and angiotension II. All vasopressors will be administered by intravenous infusion.

The monitoring of MAP and adjustment of vasopressors will occur continuously.

Compliance will the study protocol will be monitored and reported back to sites by using the electronic medical records.
Intervention code [1] 331243 0
Treatment: Other
Comparator / control treatment
There will be three treatment groups that will be compared. There is no 'control' group with the three intervention groups being compared to each other.

For the purposes of this form, the 'comparator' will be 65 mmHg.
Control group
Active

Outcomes
Primary outcome [1] 341741 0
Days alive and free of vasopressors at day 90 (composite outcome involving time to death up to 90 days from randomisation, and number of days that vasopressors were administered up to day 90 from randomisation)
Timepoint [1] 341741 0
90 days after randomisation
Secondary outcome [1] 448574 0
Mean Arterial Pressure (MAP) from day 0 to day 7, or ICU discharge (whichever is sooner)
Timepoint [1] 448574 0
7 days after randomisation

Eligibility
Key inclusion criteria
Adult (greater than or equal to 18 years of age) patient receiving a vasopressor in the ICU during an unplanned admission.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Vasopressors being administered for greater than 12 hours.
2. A study MAP target is considered contraindicated, or a specific MAP target is considered indicated.
3. A brain injury or spinal cord injury.
4. Previously enrolled.

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)
A centralised web-based system (REDCap) will allow 24-hour enrolment and random allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The coordinating centre will generate the random allocation sequence using a computer software program and embed it into the REDCap system.
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
2/04/2027
Actual
Sample size
Target
2100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319174 0
Self funded/Unfunded
Name [1] 319174 0
Country [1] 319174 0
Primary sponsor type
Hospital
Name
Metro South Health
Address
Country
Australia
Secondary sponsor category [1] 321642 0
None
Name [1] 321642 0
Address [1] 321642 0
Country [1] 321642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317758 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317758 0
Ethics committee country [1] 317758 0
Australia
Date submitted for ethics approval [1] 317758 0
09/05/2025
Approval date [1] 317758 0
06/06/2025
Ethics approval number [1] 317758 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142038 0
Dr Kyle White
Address 142038 0
Princess Alexandra Hospital, Intensive Care Unit, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 142038 0
Australia
Phone 142038 0
+61 430392529
Fax 142038 0
Email 142038 0
[email protected]
Contact person for public queries
Name 142039 0
Kyle White
Address 142039 0
Princess Alexandra Hospital, Intensive Care Unit, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 142039 0
Australia
Phone 142039 0
+61 430392529
Fax 142039 0
Email 142039 0
[email protected]
Contact person for scientific queries
Name 142040 0
Kyle White
Address 142040 0
Princess Alexandra Hospital, Intensive Care Unit, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 142040 0
Australia
Phone 142040 0
+61 430392529
Fax 142040 0
Email 142040 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data cannot be shared publicly due to institutional ethics, privacy, and confidentiality regulations. Data released for research under Sect. 280 of the Public Health Act 2005 requires an application to the Director-General of Queensland Health ([email protected]).



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.