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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05850962




Registration number
NCT05850962
Ethics application status
Date submitted
29/04/2023
Date registered
9/05/2023

Titles & IDs
Public title
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Scientific title
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock - A Multicentre Randomised Controlled Trial
Secondary ID [1] 0 0
ACTRN12623000044628
Secondary ID [2] 0 0
G2200761
Universal Trial Number (UTN)
Trial acronym
REACT-SHOCK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Shock 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Individualised MAP target

No intervention: Standard MAP target - The comparator or the control group will be comprised of patients assigned to standard care, where vasopressor support will be titrated to maintain a default MAP of 65 mmHg, unless the treating clinician considers a different MAP target as more appropriate.

Active comparator: Individualised MAP target - In the intervention arm, a patient's own pre-illness mean arterial pressure (MAP) would be targeted (range: 55-95 mmHg) during vasopressor support in ICU. The pre-illness MAP will be estimated from most recent pre-illness BP readings following a standardized method (Panwar et al,. Blood Press. 2017:1-9) and will be targeted for the duration of vasopressor therapy for up to a maximum of five days. The treating clinician can tailor these BP targets as deemed suitable for current clinical state. The type of vasopressor that will be used is at the discretion of the treating clinician.

Study intervention will cease if a patient is considered well enough by the treating clinician for discharge out of ICU. If a patient is transported out of ICU for procedural intervention, then standard (non-study) treatment should be provided.


Other interventions: Individualised MAP target
The project will test an intervention that initially targets a patient's own pre-illness mean arterial pressure (MAP) during vasopressor support in ICU. The pre-illness MAP will be estimated from the most recent pre-illness BP readings recorded in medical records.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Time to death through day 14
Timepoint [1] 0 0
First 14 days of randomisation
Secondary outcome [2] 0 0
Major Adverse Kidney Events
Timepoint [2] 0 0
14 days from randomisation
Secondary outcome [3] 0 0
Renal replacement therapy free days until day 28
Timepoint [3] 0 0
28 days from randomisation
Secondary outcome [4] 0 0
Peak increase in serum creatinine levels
Timepoint [4] 0 0
28 days from randomisation
Secondary outcome [5] 0 0
Time to death through day 90
Timepoint [5] 0 0
First 90 days of randomisation
Secondary outcome [6] 0 0
Mortality
Timepoint [6] 0 0
90 days

Eligibility
Key inclusion criteria
* ICU patients aged greater than or equal to 40 years
* The patient is deemed to be in shock, defined as clinician-initiated vasopressor/inotropic therapy AND supported by any of the following within the last 24 hours:

* Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l,
* Urine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or more consecutive hours
* Respiratory rate >22 per minute
* Altered mentation (Glasgow Coma Score <14)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who are moribund, or have documented not-for-resuscitation orders
* At least 24 hours have lapsed from the time of initiation of vasopressor or inotropic support
* Patients who are either receiving or are deemed to imminently need renal replacement therapy.
* Patients who already have an increase in serum creatinine of >350 µmol/l from baseline.
* End stage renal disease
* Patients where trauma is the main reason for the current ICU admission.
* Previously enrolled in the REACT Shock RCT
* Pregnancy, if known
* Active bleeding (clinical suspicion or >2 packed red blood cells within last 24 hours)
* Insufficient (less than two) pre-illness BP readings are available.
* Patients on extracorporeal support (such as extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist device).
* Potential contraindications to either higher or lower BP targets (including but not limited to)

* Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury
* Abdominal perfusion pressure guided therapy
* Aortic injury (e.g. dissection or post-operative)
* Post cardiac surgery
* Any other condition requiring higher or lower BP target specifically

Study design
Purpose of the study
Prevention
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2028
Actual
Sample size
Target
1260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Hunter Medical Research Institute - Newcastle
Recruitment postcode(s) [1] 0 0
- Newcastle

Funding & Sponsors
Primary sponsor type
Other
Name
Rakshit Panwar
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rakshit Panwar, PhD, MD, FCICM, MBBS
Address 0 0
Country 0 0
Phone 0 0
+61240420951
Fax 0 0
Email 0 0
rakshitpanwar@hotmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT05850962