For patients with septic shock and high circulating endotoxin levels, the addition of a polymyxin B hemoperfusion treatment to standard medical therapy did not improve 28-day mortality rate, according to a study published in JAMA.
Researchers analyzed data from 450 patients with septic shock and high circulating endotoxin activity enrolled in the Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled trial of Adults Treated for Endotoxemia and Septic Shock (EUPHRATES) trial to evaluate the effect of polymyxin B hemoperfusion treatment on 28-day mortality rates compared with a sham hemoperfusion treatment.
Patients were randomly assigned to either a treatment arm or a sham arm and monitored for 28 days. Data were collected through medical records and endotoxin activity was calculated through blood assay measurements.
In the polymyxin B hemoperfusion treatment arm (n=224), 37.5% were women, 65.6% had a multiple organ dysfunction score greater than 9, the mean age was 60.9 years old, and the mean Acute Physiology and Chronic Health Evaluation score was 29.4. In the sham hemoperfusion treatment arm (n=226), 41.2% were women, 65.5% had a multiple organ dysfunction score greater than 9, the mean age was 58.8 years old, and the mean Acute Physiology and Chronic Health Evaluation score was 28.1.
The primary outcome of 28-day mortality was comparable between both arms: 37.7% in the treatment arm vs 34.5% in the sham arm (P =.49). It was also comparable among the subset of patients with a high multiple organ dysfunction score: 44.5% in the treatment arm (n=147) vs 43.9% in the sham arm (n=148; P =.49).
Serious adverse events were reported in 65.1% of the treatment arm and 57.3% of the sham arm. The most common adverse events were worsening of sepsis and septic shock and 8% of the patients in the treatment arm experienced circuit clotting.
This study lacked statistical power and was unable to further analyze data as the result of the negative primary end point.
Researchers concluded that polymyxin B hemoperfusion treatment did not improve 28-day mortality rates of patients with septic shock and high endotoxin levels more than the standard treatment of care.
This study was supported by Spectral Medical Inc. Please refer to reference for a complete list of authors’ disclosures.
Dellinger RP, Bagshaw SM, Antonelli M, et al. Effect of targeted polymyxin B hemoperfusion on 28-day mortality in patients with septic shock and elevated endotoxin level: the EUPHRATES randomized clinical trial. JAMA. 2018; 320(14):1455-1463.