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A single-center, prospective, open-label, parallel-group pilot randomized controlled trial of granulocyte and monocyte adsorption therapy with Adacolumn in ICU patients with sepsis (Adacolumn Pilot RCT)

A study to examine the feasibility and safety of granulocyte and monocyte adsorption therapy (Adacolumn) in patients with sepsis in the intensive care unit (Adacolumn Pilot RCT)

Kikuchi Kenichiro

Sapporo Medical University Hospital

291 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido

kikuchi1@sapmed.ac.jp

Kikuchi Kenichiro

Sapporo Medical University Hospital

291 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido

+81-11-611-2111

kikuchi1@sapmed.ac.jp

Pending

Aug. 17, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1. Age 18 years or older.
2. Admitted to the intensive care unit.
3. Sepsis according to the Sepsis-3 criteria, defined as suspected or confirmed
infection with an increase in the SOFA score of 2 points or more attributable
to infection.
4. Able to be enrolled within 24 hours after ICU admission, diagnosis of sepsis,
or diagnosis of septic shock.
5. At least one of the following:
- Requirement for vasopressors.
- Requirement for invasive mechanical ventilation.
- Requirement for renal replacement therapy, or presence of acute kidney injury.
- SOFA score of 6 points or more.
6. Written informed consent obtained from the patient or a legally acceptable
representative.

1. Judged by the attending investigator to have irreversible end-stage multiple
organ failure.
2. Treatment limitation, do-not-attempt-resuscitation order, or comfort care
policy already established at the time of enrollment.
3. Receiving long-term mechanical ventilation or maintenance dialysis before
enrollment.
4. Difficulty in obtaining vascular access.
5. Severe circulatory failure precluding extracorporeal circulation.
6. Severe bleeding tendency or contraindication to anticoagulation.
7. Severe leukopenia (neutrophil count less than 500/microliter).
8. Pregnancy or possible pregnancy.
9. Judged inappropriate by the principal investigator or a sub-investigator.

Both

Sepsis, Septic shock

Adacolumn group: Granulocyte and monocyte adsorption therapy using Adacolumn is
performed in addition to standard care. Up to 5 sessions, 120 minutes per
session, at a blood flow rate of 50 mL/min. The first session is targeted to
start within 6 hours after randomization. The second session is performed 12
hours (plus or minus 6 hours) after the start of the first session, the third
session 24 hours (plus or minus 6 hours) after the start of the first session,
and the fourth and fifth sessions each 24 hours (plus or minus 6 hours) after
the preceding session. Nafamostat mesilate or heparin is used for
anticoagulation; citrate-based anticoagulation is not used.
Standard care group: Standard care alone, based on the Surviving Sepsis
Campaign Guidelines and the institutional sepsis protocol.

Sepsis, Septic shock, Critical care

Granulocyte and monocyte adsorption, Blood purification

D018805

As this is a pilot randomized controlled trial, the primary outcomes are the
following feasibility measures:
1. Enrollment rate among eligible patients: proportion of randomized patients
among screened eligible patients.
2. Consent rate: proportion of patients or representatives who provided written
informed consent among those approached.
3. Rate of Adacolumn initiation within 6 hours after randomization.
4. Adacolumn treatment initiation rate: proportion of patients who started at
least one session in the Adacolumn group.
5. Treatment completion rate: proportion of patients who completed 5 sessions,
or who ended treatment before 5 sessions for prespecified medical reasons and
were judged to have completed treatment per protocol.
6. Completion rate of 28-day organ support-free days assessment.
7. Protocol deviation rate.
8. Cross-over rate: proportion of patients in the standard care group who
received Adacolumn.
9. Missing data rate.
10. Incidence of intervention-related adverse events.
```

1. 28-day organ support-free days: days alive and free of invasive mechanical
ventilation, high-flow nasal cannula, noninvasive positive pressure
ventilation, vasopressors or inotropes, and renal replacement therapy within
28 days after randomization. Death is scored as 0 days. Calculated as a
treatment policy estimand based on observed organ support regardless of
discontinuation, incompletion, cross-over, or additional therapy.
2. 28-day mortality.
3. 90-day mortality.
4. ICU mortality.
5. In-hospital mortality.
6. Ventilator-free days within 28 days after randomization.
7. Vasopressor-free days within 28 days after randomization.
8. Renal replacement therapy-free days within 28 days after randomization.
9. ICU-free days within 28 days after randomization.
10. Hospital-free days within 28 days after randomization.
11. Length of ICU stay.
12. Length of hospital stay.
13. SOFA score on days 0, 1, 3, 5, 7, 14, and 28.
14. DIC score on days 0, 1, 3, 5, and 7.
15. Lactate on days 0, 1, 3, 5, and 7.
16. Inflammatory and coagulation markers: white blood cell count, neutrophil
count, lymphocyte count, neutrophil-to-lymphocyte ratio, C-reactive protein,
procalcitonin, interleukin-6, platelet count, prothrombin time-international
normalized ratio, fibrinogen, fibrin degradation products, and D-dimer.

+81-11-611-2111

July. 17, 2026

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