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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Australia
Hunter Medical Research Institute
RECRUITING
Newcastle
Contact Information
Primary
Rakshit Panwar, PhD, MD, FCICM, MBBS
rakshitpanwar@hotmail.com
+61240420951
Backup
Flonda Probert
REACTSHOCKRCT@newcastle.edu.au
Time Frame
Start Date: 2023-07-20
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 1260
Treatments
No_intervention: Standard MAP target
The comparator or the control group will be comprised of patients assigned to standard care, where vasopressor support will be titrated to maintain a default MAP of 65 mmHg, unless the treating clinician considers a different MAP target as more appropriate.
Active_comparator: Individualised MAP target
In the intervention arm, a patient's own pre-illness mean arterial pressure (MAP) would be targeted (range: 55-95 mmHg) during vasopressor support in ICU. The pre-illness MAP will be estimated from most recent pre-illness BP readings following a standardized method (Panwar et al,. Blood Press. 2017:1-9) and will be targeted for the duration of vasopressor therapy for up to a maximum of five days. The treating clinician can tailor these BP targets as deemed suitable for current clinical state. The type of vasopressor that will be used is at the discretion of the treating clinician.~Study intervention will cease if a patient is considered well enough by the treating clinician for discharge out of ICU. If a patient is transported out of ICU for procedural intervention, then standard (non-study) treatment should be provided.
Related Therapeutic Areas
Sponsors
Leads: Rakshit Panwar

This content was sourced from clinicaltrials.gov