Critically ill children with hypotension Circulatory System Hypotension
Conditions
Interventions
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 s
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
37 Weeks to 16 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 11/08/2023: 1. Age >37 weeks corrected gestational age and 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness: Composite of mortality and duration of ventilator support, defined by the Paediatric Critical Care Minimum Dataset (PCCMDS), from randomisation to day 30 Cost-effectiveness: Incremental net monetary benefit (INB), evaluated at the NICE recommended threshold of £20,000 per quality-adjusted life-year (QALY), at 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/06/2025: 1. Mortality collected via sites on case report form (CRF) at PICU discharge, 30 days, 90 days and 12 months 2. Duration of survival collected via sites on CRF and NHS digital if necessary to 12 months 3. Time to liberation from invasive ventilation, collected via sites on CRF, from PICU admission to PICU discharge 4. Functional status measured by the Pediatric Overall Performance Category (POPC) and Pediatric Cerebral Performance Category (PCPC) scales between PICU admission and PICU discharge 5. Receipt and duration of renal replacement therapy collected via sites on CRF and PICANet at up to 30 days (updated 17/07/2026) 6. Length of PICU and hospital stay collected via sites on CRF from PICU admission to PICU discharge 7. Health-related quality of life (HrQoL), measured by the child self- or parent-proxy reported PedsQL-4.0 with age-appropriate versions covering the wide range included in the trial (1 month-16 years) and the Child Health Utility 9D Index (CHU-9D), at 1 year 8. Incremental costs measured using CRF data, PICANet and NHS Digital at 30 days _____ Previous secondary outcome measures: 1. Mortality collected via sites on case report form (CRF) at PICU discharge, 30 days, 90 days and 12 months 2. Duration of survival collected via sites on CRF and NHS digital if necessary to 12 months 3. Time to liberation from invasive ventilation, collected via sites on CRF, from PICU admission to PICU discharge 4. Functional status measured by the Pediatric Overall Performance Category (POPC) and Pediatric Cerebral Performance Category (PCPC) scales between PICU admission and PICU discharge 5. Receipt of renal replacement therapy collected via sites on CRF and PICANet at 30 days 6. Length of PICU and hospital stay collected via sites on CRF from PICU admission to PICU discharge 7. Health-related quality of life (HrQoL), measured by the child self-or parent-proxy reported PedsQL-4.0 with age-appropriate versions | — |
Countries
England, Ireland, Scotland, Switzerland, United Kingdom, Wales
Outcome results
None listed