HA-330 hemoadsorption in septic shock requiring high-dose norepinephrine: a multicenter randomized controlled trial...

Inflammatory cytokines play a pivotal role in septic shock, driving tissue injury and circulatory failure. Hemoadsorption has been proposed as an extracorporeal strategy that removes inflammatory mediators. Patient selection and treatment timing may be integral to clinical benefit.

To determine whether adjunctive hemoadsorption with the HA-330 cytokine adsorber reduces 28-day mortality in patients with septic shock requiring high-dose vasopressors, compared with standard treatment alone.

This multicenter, randomized controlled trial enrolled patients with septic shock requiring norepinephrine ≥ 0.2 mcg/kg/min at two tertiary care centers in Thailand. Participants were assigned 1:1 to standard treatment alone (ST group) or standard treatment with two 3-hour sessions of hemoadsorption using HA-330 (HA group). The primary outcome was 28-day mortality. The trial was terminated early at the second pre-planned interim analysis due to slow recruitment and funding constraints before reaching the planned sample size of 206 participants.

A total of 128 participants were enrolled; 65 were assigned to the ST group and 63 to the HA group. The median age was 67 years, and baseline characteristics were largely comparable between groups. By day 28, 38 of 65 (58%) participants in the ST group and 28 of 63 (44%) in the HA group had died (relative risk, 0.76; 95% CI, 0.54-1.07; P = 0.16; hazard ratio, 0.68; 95% CI, 0.44-1.07; P = 0.09). No significant differences were observed in organ support-free days, shock reversal, vasopressor doses, or inflammatory markers. In a post-hoc Cox model adjusted for IL-6 (log-transformed) and VIS at hour 0, the hazard ratio for 28-day mortality was 0.62 (95% CI, 0.39-0.97; P = 0.037). No serious adverse events were reported in either group.

In this randomized trial which was terminated early, adjunctive hemoadsorption with HA-330 in patients with septic shock requiring high-dose vasopressors did not statistically reduce 28-day mortality.

ClinicalTrials.gov (NCT05136183); registered November 29, 2021.