In patients aged 65 years or older receiving vasopressors for vasodilatory hypotension, the use of permissive hypotension did not reduce all-cause 90-day mortality, according to study results published in the JAMA.
In the 65 trial (ISRCTN Registry ID: ISRCTN10580502), patients in the intensive care unit with vasodilatory hypotension were randomly assigned 1:1 to receive vasopressors guided to either a mean arterial pressure target of 60 to 65 mm Hg (permissive hypotension group) or according to usual care (usual care group). The primary clinical outcome of all-cause mortality at 90 days was evaluated between groups.
Of the 2598 participants of the study, 1291 were randomly assigned to the permissive hypotension group and 1307 to the usual care group. Patients in the permissive hypotension group had lower exposure to vasopressors (33 vs 38 hours) compared with patients in the usual care group. At 90 days, 41.0% in the permissive hypotension group had died compared with 43.8% in the usual care group (absolute risk difference, -2.85%; 95% CI, -6.75 to 1.05; P =.15). The decrease in mortality from treatment with permissive hypotension did not reach statistical significance. Serious adverse events were reported in 6.2% of patients in the permissive hypotension group and 5.8% in the usual care group.
“The results suggest that there may be no harm associated with permissive hypotension and the corresponding significant reductions in exposure to vasopressors, but the study interpretation must be limited because this was not designed as a noninferiority trial,” the researchers wrote.
Lamontagne F, Richards-Belle A, Thomas K, et al; for the 65 trial investigators. Effect of reduced exposure to vasopressors on 90-day mortality in older critically ill patients with vasodilatory hypotension: a randomized clinical trial [published online February 12, 2020]. JAMA. doi:10.1001/jama.2020.0930