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

Recruiting now · Not applicable

Conditions studied: Critical Illness, Shock

In brief

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.

Key facts

Study ID

NCT05850962

Run by

Rakshit Panwar

People needed

1260

Starts

2023-07-20

Expected to finish

2028-10-30

Last updated by the study team

2024-06-07

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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)
• Post cardiac surgery
• Any other condition requiring higher or lower BP target specifically

Where it is running

• Hunter Medical Research Institute — Newcastle, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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