Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock

Critical Illness Clinical Trial

— REACT-SHOCK  

Official title:

Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock - A Multicentre Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850962
• Other study ID #: G2200761
• Secondary ID: ACTRN12623000044
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: October 30, 2028

Study information

• Verified date: June 2024
• Source: University of Newcastle, Australia
• Contact: Rakshit Panwar, PhD, MD, FCICM, MBBS
• Phone: +61240420951
• Email: rakshitpanwar[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1260
• Est. completion date: October 30, 2028
• Est. primary completion date: January 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

• Critical Illness
• Shock

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Australia	Hunter Medical Research Institute	Newcastle	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Rakshit Panwar

Country where clinical trial is conducted

Australia, 

References & Publications (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. — View Citation

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. — View Citation

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 Mul — View Citation

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;70:154 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All deaths from randomisation to 14 days	14 days
Secondary	Time to death through day 14		First 14 days of randomisation
Secondary	Major Adverse Kidney Events	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.	14 days from randomisation
Secondary	Renal replacement therapy free days until day 28		28 days from randomisation
Secondary	Peak increase in serum creatinine levels		28 days from randomisation
Secondary	Time to death through day 90		First 90 days of randomisation
Secondary	Mortality	All deaths from randomisation to 90 days	90 days