Status: Closed to patient recruitment
What is this study about?
The optimal blood pressure target to guide treatment in critical care is not known. It is, however, well-known that both very low blood pressure (severe hypotension) and adverse effects from medical interventions (e.g. vasopressor medication) that increase blood pressure can increase the risk of death.
Current guidelines recommend that clinicians aim to reach a mean arterial pressure (MAP – a person’s average blood pressure) of 65 mmHg or more during vasopressor treatment. These guidelines are based on low quality evidence and no guidance is given on an upper limit. Previous research shows MAP values in critical care units frequently rise significantly higher than 65 mmHg, thus potentially exposing patients to potentially unnecessary doses of vasopressors and associated side-effects. There is emerging evidence which suggests that using a lower MAP target (permissive hypotension) to guide treatment may increase survival in older critically ill patients, however a large clinical trial is needed to fully evaluate this idea.
The 65 trial will evaluate, in a pragmatic, randomised clinical trial, the clinical and cost-effectiveness of using a strategy of permissive hypotension (MAP target range of 60 - 65 mmHg) during vasopressor treatment with the approach that is currently being used in the NHS, in older adults admitted to a critical care unit with vasodilatory hypotension. The trial will take place at 65 adult, general, critical care units around the UK and will include 2,600 patients.
This study uses data from the Case Mix Programme.
When is it taking place?
The trial is due to start patient recruitment in the summer of 2017 and complete in early 2019.
Who is leading the study?
Mr Paul Mouncey, ICNARC
Dr François Lamontagne, Université de Sherbrooke, Canada
This study is funded by the National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (Project: 15/80/39)