Actively Recruiting
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Led by Rakshit Panwar · Updated on 2024-06-07
1260
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ICU patients aged greater than or equal to 40 years
- Patient is in shock defined by clinician-initiated vasopressor/inotropic therapy
- Evidence of shock supported by at least one of the following within last 24 hours: lactate e2 mmol/l or base deficit e3 mmol/l, urine output 0.5 ml/kg/h or <40 ml/h for 2+ hours, respiratory rate >22 per minute, altered mentation (Glasgow Coma Score <14)
You will not qualify if you...
- Patients who are moribund or have not-for-resuscitation orders
- More than 24 hours since starting vasopressor or inotropic support
- Receiving or imminently needing renal replacement therapy
- Serum creatinine increase >350 bcmol/l from baseline
- End stage renal disease
- Trauma as main reason for ICU admission
- Previously enrolled in the REACT Shock RCT
- Known pregnancy
- Active bleeding with clinical suspicion or >2 packed red blood cells in last 24 hours
- Less than two pre-illness blood pressure readings available
- Patients on extracorporeal support (e.g., ECMO, intra-aortic balloon pump, ventricular assist device)
- Contraindications to higher or lower blood pressure targets including cerebral perfusion pressure guided therapy, abdominal perfusion pressure therapy, aortic injury, post cardiac surgery, or other specific conditions requiring different BP targets
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Trial Site Locations
Total: 1 location
1
Hunter Medical Research Institute
Newcastle, New South Wales, Australia
Actively Recruiting
Research Team
R
Rakshit Panwar, PhD, MD, FCICM, MBBS
CONTACT
F
Flonda Probert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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