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NCT Number: NCT05850962

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualised MAP target

Other

The project will test an intervention that initially targets a patient's own pre-illness mean arterial pressure (MAP) during vasopressor support in ICU. The pre-illness MAP will be estimated from the most recent pre-illness BP readings recorded in medical records.

Primary outcomes

  1. Mortality

    Time frame: 14 days

    All deaths from randomisation to 14 days

Secondary outcomes

  1. Time to death through day 14

    Time frame: First 14 days of randomisation

  2. Major Adverse Kidney Events

    Time frame: 14 days from randomisation

    Defined as a composite of death, new renal replacement therapy, or final serum creatinine level >= 200% of the latest preillness creatinine level, as assessed from patient medical records.

  3. Renal replacement therapy free days until day 28

    Time frame: 28 days from randomisation

  4. Peak increase in serum creatinine levels

    Time frame: 28 days from randomisation

  5. Time to death through day 90

    Time frame: First 90 days of randomisation

  6. Mortality

    Time frame: 90 days

    All deaths from randomisation to 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Flonda Probert

CONTACT

[email protected]

Rakshit Panwar, PhD, MD, FCICM, MBBS

CONTACT

[email protected]

+61240420951

Sponsors and collaborators

Lead sponsor

Rakshit Panwar

Other

Registry information

Official study title

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

Acronym: REACT-SHOCK

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 9, 2023
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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