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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05850962
Registration number
NCT05850962
Ethics application status
Date submitted
29/04/2023
Date registered
9/05/2023
Date last updated
7/06/2024
Titles & IDs
Public title
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
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Scientific title
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock - A Multicentre Randomised Controlled Trial
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Secondary ID [1]
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ACTRN12623000044628
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Secondary ID [2]
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G2200761
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Universal Trial Number (UTN)
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Trial acronym
REACT-SHOCK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Shock
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mortality
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Assessment method [1]
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All deaths from randomisation to 14 days
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Timepoint [1]
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14 days
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Secondary outcome [1]
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Time to death through day 14
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Assessment method [1]
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Timepoint [1]
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First 14 days of randomisation
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Secondary outcome [2]
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Major Adverse Kidney Events
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Assessment method [2]
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Defined as a composite of death, new renal replacement therapy, or final serum creatinine level >= 200% of the latest preillness creatinine level, as assessed from patient medical records.
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Timepoint [2]
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14 days from randomisation
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Secondary outcome [3]
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Renal replacement therapy free days until day 28
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Assessment method [3]
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Timepoint [3]
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28 days from randomisation
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Secondary outcome [4]
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Peak increase in serum creatinine levels
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Assessment method [4]
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Timepoint [4]
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28 days from randomisation
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Secondary outcome [5]
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Time to death through day 90
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Assessment method [5]
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Timepoint [5]
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First 90 days of randomisation
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Secondary outcome [6]
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Mortality
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Assessment method [6]
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All deaths from randomisation to 90 days
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Timepoint [6]
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90 days
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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)
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/10/2028
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Actual
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Sample size
Target
1260
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Hunter Medical Research Institute - Newcastle
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Recruitment postcode(s) [1]
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- Newcastle
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rakshit Panwar
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Aim The aim of the proposed RCT is to determine effectiveness of a strategy, where MAP (mean
arterial blood pressure) targets during vasopressor therapy for shock in ICU are
individualized based on patients' own pre-illness MAP that would be derived as an average of
up to five most recent pre-illness blood pressure readings.
Hypothesis We hypothesize that targeting a patient's pre-illness MAP during management of
shock can minimize the degree of MAP-deficit (a measure of relative hypotension), which may
help reduce the risk of 14-day mortality and major adverse kidney events by day 14 in ICU.
Endpoints The primary endpoint will be the all-cause mortality rate at day 14. Secondary
endpoints will be the time to death through day 14 and day 90, major adverse kidney events
(MAKE-14), renal replacement therapy (RRT) free days until day 28, and 90-day all-cause
mortality.
Significance To date no major RCT has tested this strategy among ICU patients with shock.
This pivotal trial will provide evidence to fulfil a crucial knowledge gap regarding a common
and a fundamental intervention in critical care.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05850962
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Trial related presentations / publications
Panwar R. Untreated Relative Hypotension Measured as Perfusion Pressure Deficit During Management of Shock and New-Onset Acute Kidney Injury-A Literature Review. Shock. 2018 May;49(5):497-507. doi: 10.1097/SHK.0000000000001033.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Rakshit Panwar, PhD, MD, FCICM, MBBS
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Address
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Country
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Phone
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+61240420951
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05850962
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