Anemia Associated With End Stage Renal Disease, CKD (Chronic Kidney Disease) Stage 5D, Dialysis Related Complication, Hemodialysis, Inflammation Biomarkers, Inflammation Chronic, Uremia; Chronic, Uremic; Toxemia
Conditions
Keywords
Program dialysis, Sorption, Complications of program dialysis
Brief summary
Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia
Detailed description
This study will involve 30 hemodialysis patients selected based on examination results showing elevated C-reactive protein (CRP) and/or interleukin-6 (IL-6) levels. Participants will undergo hemoadsorption with the Jafron HA130 cartridge performed concurrently with hemodialysis: three times per week during the first month, twice per week during the second month, and once per week during the third month. The following parameters will be assessed: inflammatory markers (CRP, IL-1, IL-6, IL-8, β2-microglobulin, free light chains of immunoglobulins), parathyroid hormone (PTH), standard biochemical blood tests (creatinine, urea, calcium, phosphorus, albumin, iron metabolism), and complete blood count. Analyses will be performed at baseline (before inclusion) and monthly thereafter.
Interventions
DEVICEPatients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.
The test cartridge will be used in addition to the ongoing program hemodialysis three times a week in the first month, twice a week in the next month, once a week in the third month
Sponsors
Botkin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will comprise two groups of 30 participants each. The intervention group will receive standard hemodialysis with adjunctive hemosorption therapy using the Jafron HA130 cartridge, while the control group will receive standard hemodialysis treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adequate dialysis defined by a KT/V index ≥ 1.4 2. No active inflammatory process or infection 3. Age ≥ 18 years 4. Receiving standard hemodialysis regimen three times weekly, at least 4 hours per session 5. Participants with elevated interleukin-6 (IL-6) and/or C-reactive protein (CRP) levels exceeding local laboratory reference values
Exclusion criteria
1. Current use of steroids or immunosuppressive therapy 2. History of kidney transplantation 3. Diagnosis of cancer 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in serum IL-6, pg/ml | By the third month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in serum IL-8, pg/ml | Monthly for 3 months | — |
| Change from baseline in serum IL-10, pg/ml | Monthly for 3 months | — |
| Change from baseline in CRP, mg/L | Monthly for 3 months | — |
| Change from baseline in β2-microglobulin, mg/L | Monthly for 3 months | — |
| Change from baseline in free light chains, mcg/ml | Monthly for 3 months | — |
| Change from baseline in PTH, pg/ml | Monthly for 3 months | — |
| Change from baseline in serum iron, mcg/dL | Monthly for 3 months | — |
| Change from baseline in ferritin, mcg/L | Monthly for 3 months | — |
| Change frome baseline in serum IL-1, pg/ml | Monthly for 3 months | — |
| Change from baseline in albumin, g/L | Monthly for 3 months | — |
| Change from baseline in phosphorus, mmol/L | Monthly for 3 months | — |
| Change from baseline in calcium, mmol/L | Monthly for 3 months | — |
| Change from baseline in blood urea nitrogen (BUN), mmol/L | Monthly for 3 months | — |
| Change from baseline in creatinine, mg/dL | Monthly for 3 months | — |
| Change from baseline in hemoglobin (Hb), g/L | Monthly for 3 months | — |
| Change from baseline in Hospital Anxiety and Depression Scale Score | Monthly for 3 months | Scale consists of two subscales. The minimum score of each is 0, and the maximum score on each of the two subscales is 21. The higher the score, the higher the level of anxiety and depression. |
| Change from baseline in pruritus (Visual Analogue Scale) | Monthly for 3 months | From 0 to 10 where 10 is maximum |
| Change from baseline in saturated transferrin, TS% | Monthly for 3 months | — |
Countries
Russia
Contacts
Primary ContactEvgeny V Shutov, PhD
Outcome results
None listed