Kinetics of Extracellular Vesicles in Hemodialysis

NCT05957146 | Completed

• 1 other identifier: NL84115.018.23
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to gain insight into the kinetics of extracellular vesicles (EVs), derived from both in- (i.e. bio-incompatibility) and outside (tissue-injury) the extracorporeal circuit (ECC), during standard hemodialysis (HD) in adult prevalent end-stage kidney disease (ESKD) patients treated with HD. During a single HD session, blood samples for EV-assessment will be taken at several time points and at different sampling sites in the extracorporeal circuit (sampling point 1: before the rollerpump, arterial line; sampling point 2: after the rollerpump and before the dialyzer, sampling point 3: after the dialyzer, efferent line).

Conditions

End-stage Kidney Disease

Keywords

Hemodialysis; Extracellular vesicles; Bio-incompatibility; Tissue injury

Outcome Measures

Primary Outcomes (1)

• Intradialytic change in the concentration of extracellular vesicles from specific cell types

  Blood cell-derived EVs: platelets: CD61+, activated platelets: CD61+/CD62p+; erythrocytes: CD235a+; leukocytes CD45+; and endothelium-derived EVs: CD144+, activated endothelium CD62e+; myocardium and endothelium-derived: Connexin-43+ will be measured at different sampling sites (sampling point 1: before the roller pump, arterial line; sampling point 2: after the rollerpump and before the dialyzer, sampling point 3: after the dialyzer, efferent line).

  4 hours (=one dialysis treatment); assessed at the following time points: 0 minutes (start of dialysis), 30 min, 60 min, 120 min, 180 min, 235 minutes

Secondary Outcomes (5)

• Intradialytic blood pressure

  4 hours (=one dialysis treatment); measured 4x/hour

• Hematocrit (Ht)

  4 hours (=one dialysis treatment); measured three times (at the start (0 minutes), half way (120 minutes) and at the end (240 minutes))

• High sensitive CRP (hsCRP)

  4 hours (=one dialysis treatment); measured once at the start of dialysis (0 minutes)

• White blood cell (WBC) count

  4 hours (=one dialysis treatment); measured once at the start of dialysis (0 minutes)

• Platelet count

  4 hours (=one dialysis treatment); measured once at the start of dialysis (0 minutes)

Study Arms (1)

Chronic hemodialysis patients

Adult patients treated with routine hemodialysis 3x/week during at least 3 months

Device: Routine hemodialysis

Interventions

Routine hemodialysis DEVICE

* Dialyzers: Cordiax FX80 dialyzers; membrane material HelixonePlus (polysulfone); (Fresenius Medical Care Bad Homburg, Germany) * Dialysis machines: Baxter Gambro AK 98 (Gambro Lundia AB, Lund, Sweden; part of Baxter Healthcare Corporation) * Needles for vascular access: Nipro SafeTouch dialysis cath 1.6x25 mm (16G) or 1.9x25 mm (15G); or Nipro SafeTouch Tulip needles (15G; all Nipro Medical Europe Mechelen, Belgium) * Ultrapure dialysis fluids (less than 0.1 colony forming units/ml, less than 0.03 endotoxin units/ml) will be mixed with AC-F 219/1 or 213/4 liquid acid concentrates and BiBag dry bicarbonate concentrate. Hence, the electrolyte composition of the dialysis fluid will be: Na 138-142 mmol/L; K 2.0-3.0 mmol/L; HCO3 26-35 mmol/L; Ca 1.25-1.50 mmol/L; Mg 0.5 mmol/L; Cl 108.5-109 mmol/L; glucose 5.6 mmol/L; acetate 3 mmol/L. Dialysate flow rate will be 500 mL/min. * Anticoagulation: nadroparin.

Chronic hemodialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients treated with chronic intermittent hemodialysis (3x per week during 4 hours) during at least 3 months

You may qualify if:

• Age \>18 years
• Stable clinical situation: free of infection, no recent admission
• HD \>3 months
• Haemoglobin level \>6,2 mmol/L
• Residual diuresis \<200mL/24h
• Willing and able to give written informed consent.

You may not qualify if:

• Active infection, malignancy, auto-immune disease, or treatment with immunosuppressive medication.
• Allergy to polysulfone dialysers
• Life expectancy \<3 months due to non-renal disease
• Access recirculation

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Dianet Dialysis Centers: collaborator

Study Sites (1)

Dianet Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muriel PC Grooteman, MD PhD

  VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD PhD

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 24, 2023
• Study Start: November 7, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)