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Recruiting Not applicable NCT05850962

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

No applicable phase (e.g. observational)
Conditions: Critical Illness Shock

Sponsor: Rakshit Panwar

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 1
Australia (1)
Hunter Medical Research Institute
Newcastle , New South Wales
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Healthy volunteers
No
Start date
20.07.2023
Completion date
30.10.2028
Registry ID
NCT05850962
Source
anzctr
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