End Stage Kidney Disease (ESRD), Sepsis, The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD
Conditions
Keywords
Superhighflux, hemodialysis, end stage kidney disease, sepsis
Brief summary
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.
Detailed description
Sepsis in people who have ESKD is the risk of developing poor outcome. Cytokines play a role in the process of sepsis and cause the worsening clinical outcome despite definitive antibiotic treatment. Superhigh-flux dialyzer has a larger molecular weight cut off (MWCO) clearance, include cytokine, could contribute to improved sepsis management in individuals with ESKD. This study is conducted to prove the efficacy of super high-flux dialyzer comparing with high-flux dialyzer in case of mortality reduction for regular hemodialysis ESKD patients. Method This study is an open label single center randomized control trial. We randomized ESKD patients who have sepsis condition with high interleukin-6 (IL-6 \> 50 pg/ml). The participants were allocated to super high-flux dialyzer group and high flux dialyzer group, stratified with diabetes, vascular access, and septic shock. We excluded; patient who needed dialysis with continuous kidney replacement therapy, vulnerable patient, include pregnant woman, patient who closed and patient who expected to pass away within the 24 hours. We aim to enroll total 202 participants; divided equally in each arm. According to our protocol, non reused super high-flux dialyzer and high-flux dialyzer are used in the same assigned patient in first week without crossing over. The standard of care of sepsis and antibiotic are provided in both groups without intervening of researcher and our protocol. The primary endpoint is 28 days of mortality. The secondary outcome include cardiovascular death, rate reduction of IL-6 after dialysis, days of hospitalization, ventilator free days and complication of dialysis are also monitored.
Interventions
DEVICESuper High-flux dialyzer (Elisio 19HDx)
Dialysis with Super High-flux dialyzer for intervention group
DEVICEHigh-flux dialyzer (Elisio 19H)
Dialysis with High-flux dialyzer for control group
Sponsors
Navamindradhiraj University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Comparing the mortality in sepsis condition between two groups of ESKD patient who underwent hemodialysis with superhighflux and highflux dialyzer
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ESKD patients who have sepsis condition with high interleukin-6 (IL-6 \> 50 pg/ml)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the reduction of all cause death at 28 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration of inotrope weaning | 14 days | — |
| The duration of hospitalization | 28 days | — |
| Ventilator free days | 28 days | — |
| Comparing the difference of blood level of IL-6, ESR, CRP and albumin, before and after of the first dialysis session, in each group. | 7 days | — |
| The incidence rate of complication of dialyzer in each group | 28 days | The incidence rate of complication of dialyzer; allergic reaction, clotting of dialyzer etc. |
| The adequacy profile of dialysis in both groups | 7 days | — |
| The incidence of intradialytic hypotension | 28 days | — |
Countries
Thailand
Contacts
Primary ContactPunnawit Laungchuaychok, MD
Backup ContactWanjak Pongsittisak, MD
Outcome results
None listed