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

University of Indonesia (UI)

Status: Enrolling

Conditions: Hemodialysis; Sepsis; Renal Dysfunction

Treatments: Device: Conventional Hemodialysis; Device: Ha-330 Hemoperfusion Filter Hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05941624

IndonesiaUAnes043

Details and patient eligibility

About

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

Full description

This study is an open randomized clinical trial. Data were taken prospectively until the number of samples was fulfilled for analysis. Due to the intervention provided, this study was not blinded. Subjects were divided into 2 groups (group undergoing conventional hemodialysis and group undergoing HA330 hemoperfusion). Both groups underwent therapy for 4 hours, 3 times a week, with two days apart between dialysis. Inflammatory mediator levels were assessed 4 times, before and after each intervention. All subjects were given standard therapy as indicated such as antibiotics, oxygen supplementation, administration of vasopressors, nutrition, and other therapies as indicated.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Ha-330 Hemoperfusion Filter Hemodialysis

Experimental group

Description:

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

Treatment:

Device: Ha-330 Hemoperfusion Filter Hemodialysis

Conventional hemodialysis

Active Comparator group

Description:

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

Treatment:

Device: Conventional Hemodialysis