Hunter Medical Research Institute
Newcastle, New South Wales, Australia
Location status: Recruiting
Location contact
Flonda Probert
CONTACT
Naomi Knoblauch
CONTACT
NCT Number: NCT05850962
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.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Newcastle, New South Wales, Australia
Location status: Recruiting
Flonda Probert
CONTACT
Naomi Knoblauch
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 14 days
All deaths from randomisation to 14 days
Time frame: First 14 days of randomisation
Time frame: 14 days from randomisation
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.
Time frame: 28 days from randomisation
Time frame: 28 days from randomisation
Time frame: First 90 days of randomisation
Time frame: 90 days
All deaths from randomisation to 90 days
Contact information is provided by the study sponsor or research team.
Flonda Probert
CONTACT
Rakshit Panwar, PhD, MD, FCICM, MBBS
CONTACT
Rakshit Panwar
Other
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock - A Multicentre Randomised Controlled Trial
Acronym: REACT-SHOCK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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