Critical Illness, Shock
Conditions
Keywords
Relative hypotension
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.
Interventions
OTHERIndividualised MAP target
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.
Sponsors
Rakshit Panwar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 14 days | All deaths from randomisation to 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Kidney Events | 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. |
| Renal replacement therapy free days until day 28 | 28 days from randomisation | — |
| Time to death through day 14 | First 14 days of randomisation | — |
| Time to death through day 90 | First 90 days of randomisation | — |
| Mortality | 90 days | All deaths from randomisation to 90 days |
| Peak increase in serum creatinine levels | 28 days from randomisation | — |
Countries
Australia
Contacts
Primary ContactRakshit Panwar, PhD, MD, FCICM, MBBS
Backup ContactFlonda Probert
Outcome results
None listed