Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Hemodialysis Filter

NCT05941624 | Completed

• 1 other identifier: IndonesiaUAnes043
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness between conventional hemodialysis and hemodialysis using hemoperfusion adsorbents in renal dysfunction caused by sepsis

Conditions

Renal Dysfunction; Sepsis; Hemodialysis

Outcome Measures

Primary Outcomes (4)

• Change in Interleukin (IL)-1Ra concentration before and after hemodialysis

  IL-1Ra measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. IL-1Ra will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  1 week

• Change in Interleukin (IL)-6 concentration before and after hemodialysis

  IL-6 measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. IL-6 will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  1 week

• Change in Interleukin (IL)-10 concentration before and after hemodialysis

  IL-10 measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. IL-10 will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  1 week

• Change in Tumor Necrosis Factor (TNF)-a concentration before and after hemodialysis

  TNF-a measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. TNF-a will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  1 week

Secondary Outcomes (27)

• Leukocytes Levels

  1 week

• Neutrophils Levels

  1 week

• Lymphocytes Levels

  1 week

• Thrombocytes Levels

  1 week

• C-Reactive Protein (CRP) Levels

  1 week

Study Arms (2)

Ha-330 Hemoperfusion Filter Hemodialysis

EXPERIMENTAL

Participants underwent therapy using Ha-330 Hemoperfusion Filter Hemodialysis for 4 hours, 3 times a week, with two days apart between dialysis.

Device: Ha-330 Hemoperfusion Filter Hemodialysis

Conventional hemodialysis

ACTIVE COMPARATOR

Participants underwent therapy using Conventional Hemodialysis for 4 hours, 3 times a week, with two days apart between dialysis.

Device: Conventional Hemodialysis

Interventions

Ha-330 Hemoperfusion Filter Hemodialysis DEVICE

a total of 4 hours therapy, 3 times a week. Each therapy should be two days apart

Ha-330 Hemoperfusion Filter Hemodialysis

Conventional Hemodialysis DEVICE

a total of 4 hours therapy, 3 times a week. Each therapy should be two days apart

Conventional hemodialysis

Eligibility Criteria

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

You may qualify if:

• Patients age 18 - 65 years old
• Patients diagnosed with sepsis with acute kidney injury whose indicated for hemodialysis. Including fluid overload, life-threatening metabolic acidosis, hypercalcemia, pulmonary edema, and uremic

You may not qualify if:

• Patients with hemodynamic instability who need norepinephrine more than 0.5 microgram/kg/minute
• Patients denied to be included in the study

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (29)

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MeSH Terms

Conditions

Renal Insufficiency; Sepsis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dita Aditianingsih, M.D.

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Anesthesiologist Consultant

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 12, 2023
• Study Start: June 16, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)