Evaluating the use of a lower blood pressure target to guide drug treatment in critically ill children with low blood pressure

Not Applicable

• Conditions: Critically ill children with hypotension; Circulatory System; Hypotension

• Registration Number: ISRCTN20609635
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38629915/ (added 15/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-24
• Last Update Posted: 27 May 2024
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

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

Exclusion Criteria

Current 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical effectiveness:<br>Composite of mortality and duration of ventilator support, defined by the Paediatric Critical Care Minimum Dataset (PCCMDS), from randomisation to day 30<br><br>Cost-effectiveness:<br>Incremental net monetary benefit (INB), evaluated at the NICE recommended threshold of £20,000 per quality-adjusted life-year (QALY), at 90 days