Shock Syndromes I
| (c) | Australasian Resuscitation in Sepsis Evaluation (ARISE) study |
|---|---|
| (1) | Randomized ED patients in both academic and nonacademic centers mainly in |
Australia and New Zealand to either early goal-directed therapy (with the same
protocol noted previously) or usual care (treatment according to the bedside physician)
| (2) | 90-day mortality did not differ between the treatment arms (early goal-directed |
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therapy 18.6% vs. usual care 18.8%, p=0.90).
| (3) | Because the enrolled patients had lower severity-of-illness scores and lower mortality |
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at 90 days, they may have been less acutely ill than the patients enrolled in the ProCESS
trial. However, about 70% of the patients in the ARISE study had septic shock at
randomization (only 54% of the patients in the ProCESS trial met this criterion),
suggesting the patients in ARISE were critically ill and the intended population was
studied.
| (d) | Protocolised Management in Sepsis (ProMISe) study |
|---|---|
| (1) | Randomized 1260 ED patients in both academic and nonacademic centers in England |
to either early goal-directed therapy or usual care (identical to the ARISE study in
design)
| (2) | 90-day mortality did not differ between those treated with early goal-directed therapy |
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and those treated with usual care (29.5% vs. 29.2%, p=0.90).
| (3) | Patients in the early goal-directed therapy arm had higher SOFA scores at 6 hours |
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(mean 6.4 ± 3.8 vs. 5.6 ± 3.8, p<0.001), more often received advanced cardiovascular
support (37.0% vs. 30.9%, p=0.026), and had a longer ICU length of stay (median
[IQR] 2.6 [1.0–5.8] days vs. 2.2 [0.0–5.3] days, p=0.005).
| (e) | Discussion of ProCESS, ARISE, and ProMISe studies |
|---|---|
| (1) | In a systematic review and meta-analysis that included the ProCESS, ARISE, and |
ProMISe studies, early goal-directed therapy was not associated with a difference
in mortality compared with control (OR 1.01; 95% CI, 0.88–1.16; p=0.9), but it was
associated with increased vasopressor use (OR 1.25; 95% CI, 1.10–1.41; p<0.001) and
more frequent ICU admission (OR 2.19; 95% CI, 1.82–2.65; p<0.001).
| (2) | Patients in these studies received about 30 mL/kg of crystalloid solution before study |
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enrollment. This is significantly different from the patients in the landmark early goal-
directed therapy study, in which patients were enrolled before resuscitation.
| (3) | The ARISE and ProMISe studies required antimicrobial administration before |
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enrollment. In ProCESS, 76% of patients had antimicrobials administered before
enrollment and 97% within 6 hours of enrollment. In the landmark early goal-directed
therapy study, only 86% of patients had antimicrobials administered within 6 hours
of enrollment.
| (4) | These studies highlight the benefits of timely administration of antibiotics and |
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intravenous fluids, which should be a focus of the early care of patients with sepsis
and septic shock.
| (5) | 51%–62% of patients in the usual care arms of these studies had a central venous |
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catheter inserted, even though it was not required in the study protocol.
| (6) | The consistent findings of lower mortality rates in the contemporary studies suggest |
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that care of patients with septic shock has evolved since the landmark early goal-
directed therapy study.
| (7) | In centers with ubiquitous early recognition and aggressive resuscitation strategies, |
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protocolized care may no longer be mandatory.
| (8) | Restrictive fluid approach |
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