The so-called ProCESS study in NEJM concluded that the protocols did not improve mortality rates or reduce the need for organ support in emergency room patients diagnosed with septic shock. The study used data from 31 U.S. hospitals to evaluate the use of central lines to monitor pressure and oxygen, which could lead to use of intraveneous fluids and medications to elevate blood pressure and blood transfusions.
NQF convened the ad hoc committee to address one measure in the guidelines that focused on a subset of patients with persistent low blood pressure and elevated lactate levels (a marker for sepsis). The measure said central venous pressure and central venous oxygen saturation should be required in these patients. The 11 panelists who voted against requiring the measure said it should be left up to clinician discretion.
In an opening statement before the vote, Dr. Sean Townsend of the Surviving Sepsis Campaign, SSC, argued a vote to remove the measure would be hasty, that the ProCESS study was one of three trials being conducted, and that there is no harm in waiting for all the evidence. “Unless a therapy is shown to be harmful, there’s no need to move at light speed,” Townsend said. “This potentially charged moment comes under the threat of no imperative.”
Townsend notes that trials in Europe and Australia are ongoing, and a meta-analysis of all three studies could provide more evidence for better generalizations. SSC has received funding over its ten year history from companies like Eli Lilly, which manufactured a sepsis drug treatment called Xigris until it was removed from the market, and Edwards Lifesciences, which makes central-line catheters, according to numerous press accounts.
The sepsis guidelines have been controversial for several reasons. An article in MedPage Today last week quoted physicians claiming use of central-lines catheters had a 1 in 50 to 1 in 200 risk of causing a pneumothorax. The article also reported that placing the central lines adds roughly $500 a patient.
The lead author of the NEJM study, Dr. Don Yealy of the University of Pittsburgh, told NQF that the evidence clearly shows that use of the catheters did not improve the quality of care for patients. Other approaches are equally as good and do not expose patients to interventions that may cause harm, he added.
Following Tuesday’s vote, the NQF patient-safety committee plans to open the recommendations for public comment within the next month. An editorial posted with the release of the ProCESS study data argued that there is a pressing need to evaluate various sepsis protocols in hospitals.
“Such evaluation is particularly important if policymakers do move ahead with mandates,” said Harvard physicians, Dr. Chanu Rhee and Dr. Michael Klompas, and Dr. Shruti Gohil of the University of California at Irvine, “since forcing behavior increases the risk of unintended harms."
Follow Sabriya Rice on Twitter: @MHSRice
