An aggressive treatment protocol for septic shock is no more effective at preventing mortality or reducing use of resources than usual care, according to meta-analysis published Tuesday in the New England Journal of Medicine.
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Septic shock treatment protocol
The aggressive protocol, called early goal-directed therapy (EGDT), provides guidance for administering intravenous fluids, vasopressors, inotropes, and red-cell transfusion, ideally within the first six hours of sepsis management, according to MedPage Today.
The protocol was adopted by some medical centers around the globe following a 2001 study at a single center, which found that EGDT reduced hospital mortality from 46.5 percent to 30.5 percent.
Derek Angus of the University of Pittsburgh, who was involved in the newly published research, said that use of EGDT is a topic of immense debate in emergency medicine. "There is really no one (in emergency medicine) who is ambivalent about" EGDT, he said.
New research challenges 2001 findings
For the latest study, researchers conducted a meta-analysis of three large clinical trials involving a total of 3,723 patients at 138 hospitals in seven countries. They found little benefit of EGDT over usual care.
Mortality at 90 days was similar among the patients who received EGDT, at 24.9 percent, and patients who received usual care, at 25.4 percent. In addition, the researchers found that EGDT was associated with greater use of both intensive care (a mean of 5.3 days, compared to 1.6 days for patients receiving usual care) and cardiovascular support.
The researchers did not find significant differences in other outcomes. They noted that average costs trended higher for EGDT patients.
The researchers also analyzed a subgroup of the sickest patients in the three trials, but they wrote that they "found no evidence of treatment benefit with EGDT in patients with greater severity of illness, despite using several approaches to identify subgroups of very sick patients that were considerably larger than the entire population in the  trial."
Angus acknowledged that critics have noted the trials' patient population might not have been sick enough to demonstrate a benefit. Further, though the sample size was large overall, certain subgroups remained small.
The researchers wrote, "Although our analysis confirms that EGDT as a packaged protocol of care is not superior to usual care, there are still unresolved questions regarding the most effective fluid and vasopressor regimens, the role of hemodynamic monitoring, and appropriate targets in the resuscitation of patients with sepsis and septic shock" (Boyles, MedPage Today, 3/23; PRISM Investigators, New England Journal of Medicine, 3/21).
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