Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock - A Multicentre Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Rakshit Panwar
- Enrollment
- 1260
- Locations
- 1
- Primary Endpoint
- Mortality
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Rakshit Panwar
Conjoint Associate Professor
University of Newcastle, Australia
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.
Outcomes
Primary Outcomes
Mortality
Time Frame: 14 days
All deaths from randomisation to 14 days
Secondary Outcomes
- Time to death through day 14(First 14 days of randomisation)
- Major Adverse Kidney Events(14 days from randomisation)
- Renal replacement therapy free days until day 28(28 days from randomisation)
- Peak increase in serum creatinine levels(28 days from randomisation)
- Time to death through day 90(First 90 days of randomisation)
- Mortality(90 days)