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Protocol-based approach to sepsis failed to improve outcomes
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Structured protocols of care did not improve survival among patients with sepsis, according to study results published in The New England Journal of Medicine.
“This study provides strong evidence that will have immediate consequences,” Derek C. Angus, MD, MPH, chair of the department of critical care medicine at the University of Pittsburgh, said in a press release. “Many organizations have endorsed structured guidelines for sepsis treatment that often call for invasive devices early in care. But with prompt recognition and treatment of the condition, we found that these approaches do not improve outcomes, but do increase the use of hospital resources.”
Angus and colleagues conducted the Protocolized Care for Early Septic Shock (ProCESS) trial to compare two treatment protocols for sepsis with usual care. In the first protocol — early goal-directed therapy (EGDT) — central line catheters are placed in patients’ jugular veins to monitor blood pressure and oxygen levels and to deliver drugs, fluids and blood transfusions. In the second protocol — “protocolized” standard care (PSC) — there is no central catheter, just peripheral venous access. In usual care, physicians direct the treatment at bedside.
The researchers compared the two protocols with each other and also compared the protocolized care regimens with usual care. From March 2008 to May 2013, 1,351 with sepsis from 31 hospital EDs were enrolled in the trial and randomly assigned to EGDT, PSC or usual care for the first 6 hours of resuscitation.
They found that there was no difference in mortality between the three groups. At 60 days, the mortality rates were 21% in the EGDT arm, 18.2% in the PSC arm and 18.9% in the usual care arm. For protocolized care to usual care, the RR was 1.04 (95% CI, 0.82-1.31). For EGDT to PSC, the RR was 1.15 (95% CI, 0.88-1.51). There also were no differences in 90-day mortality, 1-year mortality or organ support.
“There have been many improvements in the management of sepsis in the past decade,” Angus said. “We examined whether giving the medical team step-by-step instructions to monitor and treat the effects of sepsis could improve survival rates as the previous study suggested. EGDT, PSC and usual care all offer early diagnosis and methods to deliver fluids, restore blood pressure and monitor cardiovascular function. One was not better than the other to treat the condition effectively.”
Disclosure: See study for complete list of researchers’ financial disclosures.
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