What is this study about?
In critically ill children, hypotension (low blood pressure) is common, especially in patients with severe infections and is a key feature of shock. A very low blood pressure, known as hypotension, can be dangerous, even life threatening. It can cause damage to the brain and other body systems in survivors. Many intensive care treatments are used to increase blood pressure. These include intravenous fluids and drugs, called vasoactive agents, to make the heart pump harder. However, these treatments also carry risks of side-effects and complications. Current guidelines recommend maintaining mean arterial pressure (MAP – mean arterial or average blood pressure) for children in the normal range for age. However, currently there is no clear evidence for the best target to aim for.
We therefore intend to conduct a large-scale, clinical trial to find out whether the benefits associated with a lower blood pressure target in critically ill children will outweigh the risks associated with lower MAP values and the medical interventions needed to raise blood pressure. We hope to include 1,900 children from 17 NHS paediatric intensive care units (PICUs) in the study. PRESSURE is a randomised controlled trial. This means that each child be randomly assigned to either receive the intervention, where they will be treated with a lower blood pressure target, or to receive the usual care that they would receive outside the study.
We will find out whether the lower blood pressure target was more effective than the usual blood pressure target by comparing patient outcomes in each group (intervention or usual care) at 30 days. Cambridge University Hospitals NHS Foundation Trust are sponsoring the study and have delegated responsibilites for managing the study to ICNARC. The study is due to start in Summer 2021 and end in Spring 2024.
Who is leading this study?
Dr David Inwald, Cambridge University Hospitals NHS Foundation Trust
Funding
National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (Project: NIHR128895).
Trial Registration
ISRCTN Registry Number: ISRCTN20609635
NIHR Portfolio CPMS ID: 48813