65 trial
Trial question
What is the effect of reduced exposure to vasopressors through permissive hypotension in older critically ill patients with vasodilatory hypotension?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 2455
2455 patients (1239 female, 1216 male).
Inclusion criteria: ICU patients aged 65 years or older with vasodilatory hypotension.
Key exclusion criteria: contraindications to permissive hypotension, vasopressors being used solely as therapy for bleeding, acute ventricular failure or post-cardiopulmonary bypass vasoplegia, ongoing treatment for brain injury or spinal cord injury, death perceived as imminent.
Interventions
N=1283 permissive hypotension (reducing or discontinuing exposure to vasopressors guided by mean arterial pressure target of 60-65 mmHg).
N=1300 usual care (receiving vasopressors at the discretion of treating clinicians).
Primary outcome
Death at 90 days
41%
43.8%
43.8 %
32.8 %
21.9 %
10.9 %
0.0 %
Permissive
hypotension
Usual
care
No significant
difference ↔
No significant difference in death at 90 days (41% vs. 43.8%; RR 0.93, 95% CI 0.85 to 1.03).
Secondary outcomes
No significant difference in death at ICU discharge (29.9% vs. 30.7%; RR 0.97, 95% CI 0.86 to 1.1).
No significant difference in duration of renal support among all patients (1.4 days vs. 1.5 days; AD -0.1 days, 95% CI -0.4 to 0.2).
No significant difference in duration of advanced respiratory support among all patients (4.5 days vs. 4.8 days; AD -0.3 days, 95% CI -1.1 to 0.4).
Safety outcomes
No significant differences in serious adverse events, including acute renal failure, supraventricular cardiac arrhythmia.
Conclusion
In ICU patients aged 65 years or older with vasodilatory hypotension, permissive hypotension was not superior to usual care with respect to death at 90 days.
Reference
François Lamontagne, Alvin Richards-Belle, Karen Thomas et al. Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension: A Randomized Clinical Trial. JAMA. 2020 Feb 12;323(10):938-949.
Open reference URL