Intensive
Care Medicine Published: 03
October 2021
Purpose
This study aimed at evaluating the efficacy and safety of
high-dose (> 0.2 L/kg of treated plasma per day) coupled plasma
filtration-adsorption (CPFA) in treating patients with septic shock.
Methods
Multicentre, randomised, adaptive trial, performed in 12
Italian intensive care units (ICUs). Patients aged 14 or more, admitted to the
ICU with septic shock, or had developed it during the stay were eligible. The
final outcome was mortality at discharge from the last hospital at which the
patient received care.
Results
Between May 2015, and October 2017, 115 patients were
randomised. The first interim analysis revealed a number of early deaths,
prompting an unplanned analysis. Last hospital mortality was non-significantly
higher in the CPFA (55.6%) than in the control group (46.2%, p = 0.35).
The 90-day survival curves diverged in favour of the controls early after
randomisation and remained separated afterwards (p = 0.100). An unplanned
analysis showed higher mortality in CPFA compared to controls among patients
without severe renal failure (p = 0.025); a dose–response relationship was
observed between treated plasma volume and mortality (p = 0.010).
Conclusion
The COMPACT-2 trial was stopped due to the possible harmful
effect of CPFA in patients with septic shock. The harmful effect, if present,
was particularly marked in the early phase of septic shock. Patients not
requiring renal replacement therapy seemed most exposed to the possible harm,
with evidence of a dose–response effect. Until the mechanisms behind these
results are fully understood, the use of CPFA for the treatment of patients
with septic shock is not recommended.
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