Individualized blood pressure targets for critically ill patients in shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hunter Medical Research Institute
  Newcastle, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Rakshit Panwar, PhD, MD, FCICM, MBBS
• Email: rakshitpanwar@hotmail.com
• Phone: +61240420951

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.