February 12, 2020
Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension.
What was the research question?
Does the reduction of exposure to vasopressors through permissive hypotension in older patients with vasodilatory shock, reduce 90-day mortality?
How did they do it?
A pragmatic, open, multicenter, parallel group, randomized clinical trial in 65 ICUs in the United Kingdom.
2463 patients who were ≥65 years and had vasodilatory shock requiring vasopressors, were randomized to receive permissive hypotension with vasopressors to target MAP 60-65 mmHg (1221 patients) or standard care with a target MAP at the discretion of the ICU team (1242 patients).
Primary outcome was 90-day mortality.
Secondary outcomes included ICU and hospital mortality, duration of renal support, ICU and hospital length of stay, cognitive decline at 90 days and 1 year, and quality of life at 90 days and 1 year.
What did they find?
Mean age of 75 years and 57% were men.
Permissive hypotension group had a lower exposure to vasopressors compared to the standard group (median duration 33 hours vs 38 hours, and total dose in norepinephrine equivalents median, 17.7 mg vs 26.4 mg).
Mean MAP was 66.7 mmHg vs 72.6 mmHg.
90-day mortality was not significantly better in permissive hypotension group compared to the standard group (41% vs. 43.8%, absolute risk difference, −2.85%; 95% CI, −6.75 to 1.05; P = .15).
Serious events were not different between the two groups: all adverse events (6.2% vs. 5.8%), acute renal failure (3.2% vs. 2.5%), and supraventricular cardiac arrhythmia (0.9% vs.1.0%).
Secondary endpoints were not significantly different between the two groups.
Subgroup analysis of patients with chronic hypertension revealed a lower 90-day mortality in the permissive hypotension group compared to the standard group (38.2% vs. 44.3%, OR 0.67, 95% CI, 0.49-0.85). No increase in rate of acute kidney injury was noticed in these patients.
Are there any limitations?
The study had a 90% power to detect a 6% absolute risk reduction.
The study was not powered for the Subgroup analysis.
What does it mean?
Permissive hypotension in patients with vasodilatory shock did not improve 90-day mortality compared to usual care.
No adverse events were reported with permissive hypotension.
It is safe to target MAP of 60-65 mmHg in elderly patients with vasodilatory shock.
Contrary to the SEPSISPAM trial, no increased rate of renal dysfunction in patients with chronic hypertension.