Key result
The 65 trial outlines its analysis plan comparing permissive hypotension to usual care in older adults.
Why the study?
Does permissive hypotension reduce all-cause mortality at 90 days in critically ill patients aged 65 years or over with vasodilatory hypotension?
RCT (n=2,600)
Open-label
parallel-group
Yes
Does permissive hypotension reduce all-cause mortality at 90 days in critically ill patients aged 65 years or over with vasodilatory hypotension?
This paper describes the statistical and health economic analysis plan for the 65 trial, which evaluates permissive hypotension in older critically ill patients.
Permissive hypotension safely lowers vasopressor exposure without increasing 90-day mortality; leaves open a modest survival benefit in older patients.
The 65 trial is a pragmatic, multicentre, parallel-group, open-label, randomised clinical trial of permissive hypotension (targeting a mean arterial pressure target of 60-65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial will recruit 2600 patients from 65 United Kingdom adult general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. This paper describes the proposed statistical and health economic analysis for the 65 trial.
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Thomas et al. (2020) conducted an RCT in critically ill with vasodilatory hypotension (n=2,600). Permissive hypotension vs. Usual care was evaluated on All-cause mortality at 90 days. This paper outlines the statistical and health economic analysis plan for the 65 trial evaluating permissive hypotension versus usual care in critically ill patients aged 65 years or older.
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