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

NCT05850962 | Recruiting DMC

• 2 other identifiers: G2200761ACTRN12623000044628
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Shock

Keywords

Relative hypotension

Outcome Measures

Primary Outcomes (1)

• Mortality

  All deaths from randomisation to 14 days

  14 days

Secondary Outcomes (6)

• Time to death through day 14

  First 14 days of randomisation

• Major Adverse Kidney Events

  14 days from randomisation

• Renal replacement therapy free days until day 28

  28 days from randomisation

• Peak increase in serum creatinine levels

  28 days from randomisation

• Time to death through day 90

  First 90 days of randomisation

Study Arms (2)

Standard MAP target

NO INTERVENTION

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.

Individualised MAP target

ACTIVE COMPARATOR

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: Individualised MAP target

Interventions

Individualised MAP target OTHER

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.

Individualised MAP target

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rakshit Panwar: lead

Study Sites (1)

Hunter Medical Research Institute

Newcastle, New South Wales, Australia

RECRUITING

Related Publications (6)

• 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.

  PMID: 29040214 BACKGROUND

• 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.

  PMID: 32614244 RESULT

• 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.

  PMID: 35525132 RESULT

• 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.

  PMID: 23849541 RESULT

• 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.

  PMID: 28745077 RESULT

• Panwar R, Gibberd A, Oldmeadow C, Tiruvoipati R, Aneman A, Kansal A; REACT SHOCK investigators. REACT SHOCK trial protocol and analysis plan-a multicenter randomised controlled trial comparing individualised blood pressure target versus standard blood pressure target among critically ill patients with shock. Trials. 2025 Oct 14;26(1):409. doi: 10.1186/s13063-025-09142-9.

  PMID: 41088147 DERIVED

MeSH Terms

Conditions

Critical Illness; Shock

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rakshit Panwar, PhD, MD, FCICM, MBBS

CONTACT

+61240420951; rakshitpanwar@hotmail.com

Flonda Probert

CONTACT

REACTSHOCKRCT@newcastle.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Conjoint Associate Professor

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 9, 2023
• Study Start: July 20, 2023
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)