Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavamindradhiraj University

About this trial

Comparing the efficacy of superhigh-flux dialyzer with high-flux dialyzer in ESKD patient who have sepsis to improve mortality and sepsis outcome, an open label randomized control trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ESKD patients who have sepsis condition with high interleukin-6 (IL-6 > 50 pg/ml)

Disqualifiers

Patients who needed dialysis with continuous kidney replacement therapy, vulnerable patient, include pregnant woman, patient who expected to pass away within the 24 hours.

Patients who have the history of allergic dialyzer reaction to dialyzer which used in this trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Super High-flux dialyzer (Elisio 19HDx)

    Device

    Dialysis with Super High-flux dialyzer for intervention group

  • High-flux dialyzer (Elisio 19H)

    Device

    Dialysis with High-flux dialyzer for control group

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: ESKD patient with sepsis who dialyzed with super high fluxExperimental treatment 1 intervention
Group B: ESKD with sepsis who dialyzed with high flux dialyzerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comparing the reduction of all cause death at 28 days

Comparing the efficacy to reduce all cause death at 28 days between Super High-flux dialyzer with High-flux dialyzer in ESKD with sepsis

Time frame
28 days

Secondary outcomes

1

Comparing the difference of blood level of IL-6, ESR, CRP and albumin, before and after of the first dialysis session, in each group.

Time frame
7 days
2

The duration of inotrope weaning

Time frame
14 days
3

The duration of hospitalization

Time frame
28 days
4

Ventilator free days

Time frame
28 days

Other outcomes

Sponsors and contacts

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