RecruitingNot ApplicableNCT05850962

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

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

Sponsor

Rakshit Panwar

Enrollment

1,260 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Critical Illness Shock

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.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

The REACT Shock RCT tests whether personalizing blood pressure targets during critical illness — specifically using a patient's own pre-illness blood pressure as a reference point rather than a generic target — can improve outcomes in ICU patients with shock. Shock is a life-threatening state where blood pressure drops so low that organs begin to fail. Standard ICU care targets a mean arterial pressure of 65 mmHg for most patients, but individual patients (especially those with chronic high blood pressure) may need higher pressures to adequately perfuse their kidneys, brain, and heart. ICU patients aged 40 or older with shock requiring vasopressor medications who have at least two pre-illness blood pressure readings available are eligible. Patients who are moribund, have already been on vasopressors for more than 24 hours, are on dialysis or about to start it, are actively bleeding, or have conditions requiring specific blood pressure management (like brain injury or aortic dissection) are excluded. This trial asks a deceptively simple but important question: should a blood pressure target that's "normal" for the average person be applied to everyone in shock, or should doctors use what's normal for that individual patient? For a 70-year-old with longstanding hypertension, a pressure of 65 might still be dangerously low for their organs. Personalizing this number could reduce ICU organ failure and save lives.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIndividualised 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.