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

Last updated: June 6, 2024
Sponsor: Rakshit Panwar
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

Individualised MAP target

Clinical Study ID

NCT05850962
G2200761
ACTRN12623000044628
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ICU patients aged greater than or equal to 40 years

  • The patient is deemed to be in shock, defined as clinician-initiatedvasopressor/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 orequal to 3 mmol/l,

  • Urine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or moreconsecutive hours

  • Respiratory rate >22 per minute

  • Altered mentation (Glasgow Coma Score <14)

Exclusion

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 orinotropic support

  • Patients who are either receiving or are deemed to imminently need renal replacementtherapy.

  • Patients who already have an increase in serum creatinine of >350 µmol/l frombaseline.

  • 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 24hours)

  • 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 notlimited to)

  • Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage orsubarachnoid 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

Study Design

Total Participants: 1260
Treatment Group(s): 1
Primary Treatment: Individualised MAP target
Phase:
Study Start date:
July 20, 2023
Estimated Completion Date:
October 30, 2028

Connect with a study center

  • Hunter Medical Research Institute

    Newcastle, New South Wales
    Australia

    Active - Recruiting

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