A multicenter randomized study comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock

Not Applicable

• Conditions: Critically ill patients with shock; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12623000044628
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1260

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:
o Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l,
o Urine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or more consecutive hours
o Respiratory rate >22 per minute
o 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)
o Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury
o Abdominal perfusion pressure guided therapy
o Aortic injury (e.g. dissection or post-operative)
o Post cardiac surgery
o Any other condition requiring higher or lower BP target specifically

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality[14 days from randomisation]

Secondary Outcome Measures

Name	Time	Method
Time to death through day 14 (assessed using medical records)[First 14 days of randomisation];Major Adverse Kidney Events (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.[14 days from randomisation];Renal replacement therapy free days until day 28 (assessed using medical record)[28 days from randomisation];Peak increase in serum creatinine levels[28 days from randomisation];Time to death through day 90 (assessed from medical record))[First 90 days of randomisation];Death[90 days from randomisation]