Individualized blood pressure targets for critically ill patients in shock

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

This study is testing if setting personalized blood pressure goals for critically ill patients in shock can help them survive better and avoid serious kidney problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1260 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of Newcastle, Australia (other)
• Locations: 1 site (Newcastle, New South Wales)
• Trial ID: NCT05850962 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of individualized mean arterial pressure (MAP) targets during vasopressor therapy for critically ill patients experiencing shock in the ICU. By using a patient's own pre-illness MAP as a reference, the study seeks to minimize relative hypotension and potentially reduce 14-day mortality and major adverse kidney events. The primary endpoint is the all-cause mortality rate at day 14, with secondary endpoints including time to death and renal outcomes. This approach is novel as no major randomized controlled trial has previously tested individualized MAP targets in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are ICU patients aged 40 years and older who are in shock and require vasopressor therapy.

Not a fit: Patients who are moribund, have not-for-resuscitation orders, or are imminently needing renal replacement therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and kidney outcomes for critically ill patients in shock.

How similar studies have performed: This approach is novel and has not been tested in major randomized controlled trials, making it an untested strategy.

Eligibility criteria

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

Where this trial is running

Newcastle, New South Wales

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

Study contacts

• Study coordinator: Rakshit Panwar, PhD, MD, FCICM, MBBS

Conditions: Critical Illness, Shock, Relative hypotension