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Compares treatment options for Critical Illness
Official title Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
ClinicalTrials.gov ID: NCT05850962
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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.
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Newcastle, New South Wales, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newcastle, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.