Trial reportCritical care (London, England)2026
HA-330 hemoadsorption in septic shock requiring high-dose norepinephrine: a multicenter randomized controlled trial (CLEANSE).
Trial report in Critical care (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05136183 (CLinical Efficacy of Hemoperfusion With a Cytokine Adsorber in Norepinephrine-Resistant SEptic Shock), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
CLinical Efficacy of Hemoperfusion With a Cytokine Adsorber in Norepinephrine-Resistant SEptic Shock
Who cites it
2 citing papers in PubMed.
- Timing of hemoadsorption in sepsis: redefining early through mediator-guided therapy.Journal of intensive care · 2026Review
- Sample size assumptions, timing asymmetries, and endpoint selection limit the interpretability of the CLEANSE hemoadsorption trial in septic shock.Critical care (London, England) · 2026Article
Corrections and comments
- Commented on by
Authors and funding
5 authors.
Funding
Abstract
backgroundInflammatory 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.
objectivesTo 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.
methodsThis 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.
resultsA 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.
conclusionsIn 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.
trial registrationClinicalTrials.gov (NCT05136183); registered November 29, 2021.
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