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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
Date last updated
7/06/2024

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
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.
Trial website
https://clinicaltrials.gov/study/NCT05850962
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.
Panwar R, Tarvade S, Lanyon N, Saxena M, Bush D, Hardie M, Attia J, Bellomo R, Van Haren F; REACT Shock Study Investigators and Research Coordinators. Relative Hypotension and Adverse Kidney-related Outcomes among Critically Ill Patients with Shock. A Multicenter, Prospective Cohort Study. Am J Respir Crit Care Med. 2020 Nov 15;202(10):1407-1418. doi: 10.1164/rccm.201912-2316OC.
Panwar R, Van Haren F, Cazzola F, Nourse M, Brinkerhoff G, Quail A. Standard care versus individualized blood pressure targets among critically ill patients with shock: A multicenter feasibility and preliminary efficacy study. J Crit Care. 2022 Aug;70:154052. doi: 10.1016/j.jcrc.2022.154052. Epub 2022 May 5.
Panwar R, Lanyon N, Davies AR, Bailey M, Pilcher D, Bellomo R. Mean perfusion pressure deficit during the initial management of shock--an observational cohort study. J Crit Care. 2013 Oct;28(5):816-24. doi: 10.1016/j.jcrc.2013.05.009. Epub 2013 Jul 10.
Panwar R, Sullohern B, Shiel E, Alexis Brown C, Quail A. Validity of a protocol to estimate patients' pre-morbid basal blood pressure. Blood Press. 2018 Feb;27(1):10-18. doi: 10.1080/08037051.2017.1358055. Epub 2017 Jul 26.
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05850962