PRESSURE: PRotocolised Evaluation of permiSSive blood pressure targets versus Usual caRE. Evaluating the clinical and cost-effectiveness of using a permissive blood pressure target to guide titration of vasoactive drugs in critically ill children with hypotension
Critically ill children with hypotension
Eligible patients will be randomised on a 1:1 basis to either permissive blood pressure targets or usual care using a central web-based randomisation service (sealed envelope). Randomisation will be stratified by site and age. Intervention group: Participants allocated to the intervention group will be treated using an allocated lower blood pressure target whilst receiving vasoactive drugs. The target allocated will depend on the participant's age. The decision to discontinue vasoactive drugs will depend on the patient's ability to maintain the target. All other usual care will be provided at the discretion of the treating clinical team, according to local practice. Usual care: Participants allocated to this group will receive usual care, according to local practice. A follow-up questionnaire will be provided to those who have agreed to it 12 months post randomisation.
Current participant inclusion criteria as of 11/08/2023: 1. Age >37 weeks corrected gestational age and <16 years 2. Enrolled within 6 hours of first meeting all the following criteria: 2.1. Accepted for or admitted to a participating PICU 2.2. Face-to-face contact with PICU staff or transport team 2.3. On invasive mechanical ventilation 2.4. Receiving a continuous infusion of vasoactive drug for hypotension 2.5. Vasoactive drug expected to continue for at least 6 hours or more _____ Previous participant inclusion criteria: 1. Age >37 weeks corrected gestational age and <16 years 2. Accepted for or admitted to PICU 3. Receiving a continuous infusion of a vasoactive drug for hypotension commenced within the previous 6 hours 4. Vasoactive drug expected to continue for at least 6 hours or more 5. On invasive mechanical ventilation
Current exclusion criteria as of 25/06/2025: 1. Admitted post cardiac surgery 2. Known cardiomyopathy 3. Neonates with suspected or proven duct dependent circulation 4. Acute brain injury 5. Currently being treated for pulmonary hypertension 6. Admitted with malignant hypertension 7. Death perceived as imminent 8. Previously recruited to PRESSURE either in the last 30 days or during the same hospital admission _____ Previous participant exclusion criteria as of 11/08/2023: 1. Admitted post cardiac surgery 2. Known cardiomyopathy 3. Neonates with suspected or proven duct dependent circulation 4. Acute brain injury 5. Currently being treated for pulmonary hypertension 6. Admitted with malignant hypertension 7. Death perceived as imminent 8. Previously recruited to PRESSURE _____ Previous participant exclusion criteria: 1. Admitted post cardiac surgery 2. Known cardiomyopathy 3. Neonates with suspected or proven duct dependent circulation 4. Brain injury 5. Pulmonary hypertension 6. Malignant hypertension 7. Death perceived as imminent 8. Previously recruited to PRESSURE