SEPSISPAM
Trial question
What is the role of high blood-pressure target in patients with septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 776
776 patients (259 female, 517 male).
Inclusion criteria: patients with septic shock.
Key exclusion criteria: legal protection (i.e., incompetence to provide consent and no guardian or incarceration), pregnancy, recent participation in another biomedical study or another interventional study with mortality as the primary end point, or an investigator's decision not to resuscitate.
Interventions
N=388 high-target (mean arterial pressure target of 80-85 mmHg).
N=388 low-target (mean arterial pressure target of 65-70 mmHg).
Primary outcome
Death at 28 days
36.6%
34%
36.6 %
27.5 %
18.3 %
9.2 %
0.0 %
High-target
Low-target
No significant
difference ↔
No significant difference in death at 28 days (36.6% vs. 34%; HR 1.07, 95% CI 0.84 to 1.38).
Secondary outcomes
No significant difference in death at 90 days (43.8% vs. 42.3%; HR 1.04, 95% CI 0.83 to 1.3).
Safety outcomes
No significant differences in serious adverse events (19.1% vs. 17.8%, p=0.64).
Significant differences in newly diagnosed AF (6.7% vs. 2.8%, p = 0.02).
Conclusion
In patients with septic shock, high-target was not superior to low-target with respect to death at 28 days.
Reference
Asfar P, Meziani F, Hamel JF et al. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93.
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