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NCT Number: NCT05941624

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ha-330 Hemoperfusion Filter Hemodialysis

Device

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

Conventional hemodialysis

Device

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

Primary outcomes

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

    Time frame: 1 week

    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.

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

    Time frame: 1 week

    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.

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

    Time frame: 1 week

    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.

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

    Time frame: 1 week

    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.

Secondary outcomes

  1. Leukocytes Levels

    Time frame: 1 week

    Leukocytes measurement using automatic hematology analyzer. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Leukocytes will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  2. Neutrophils Levels

    Time frame: 1 week

    Neutrophil measurement using automatic hematology analyzer. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Neutrophils will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  3. Lymphocytes Levels

    Time frame: 1 week

    Lymphocytes measurement using automatic hematology analyzer. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Lymphocytes will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  4. Thrombocytes Levels

    Time frame: 1 week

    Thrombocytes measurement using automatic hematology analyzer. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Lymphocytes will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  5. C-Reactive Protein (CRP) Levels

    Time frame: 1 week

    C-Reactive Protein measurement using latex agglutination method. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. CRP levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  6. Procalcitonin Levels

    Time frame: 1 week

    Procalcitonin measurement using particle enhanced immunoturbidimetric test. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Procalcitonin levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  7. Urea Levels

    Time frame: 1 week

    Urea measurement using enzymatic method (Glutamate dehydrogenase). The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Urea levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  8. Creatinine Levels

    Time frame: 1 week

    Creatinine measurement using Calorimetry. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Creatinine levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  9. Glomerular Filtration Rate (GFR)

    Time frame: 1 week

    Glomerular Filtration Rate measurement with creatinine clearance test using the Cockcroft-Gault formula

  10. Bilirubin Levels

    Time frame: 1 week

    Total bilirubin measurement with DCA method (Colorimetry test-Dichloroaniline). The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Bilirubin levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  11. Serum Glutamic Oxaloacetic Transaminase (SGOT) Levels

    Time frame: 1 week

    Serum glutamic oxaloacetic transaminase measurement with kinetic method using spectrophotometer. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. SGOT will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  12. Serum Glutamic Pyruvate Transaminase (SGPT) Levels

    Time frame: 1 week

    Serum glutamic pyruvate transaminase measurement with kinetic method using spectrophotometer. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. SGPT will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  13. Prothrombin Time (PT)

    Time frame: 1 week

    Prothrombin time measurement using optical/mechanical photo. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. PT levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  14. Activated Partial Thromboplastin Time (aPTT)

    Time frame: 1 week

    Activated partial thromboplastin Time measurement using optical/mechanical photo. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. aPTT levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  15. International Normalizing Ratio (INR)

    Time frame: 1 week

    International normalizing ratio measurement using optical/mechanical photo. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. INR will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  16. Lactate Levels

    Time frame: 1 week

    Lactate measurement using lactate oxidase. The sample is taken from 5 mL of venous blood from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Lactate levels will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  17. Blood pH (Potential Hydrogen)

    Time frame: 1 week

    Blood pH measurement using the pH indicator into blood sample for some minutes. The sample is taken from 3 mL of arterial blood from arterial catheter from baseline (1 hour before first intervention) and 1 hour after intervention. SGPT will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  18. Base Excess (BE)

    Time frame: 1 week

    Base Excess measurement using 2 methods: direct and blood gas analysis. The sample is taken from 3 mL of arterial blood from arterial catheter from baseline (1 hour before first intervention) and 1 hour after intervention. Base excess will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  19. PaO2 (Partial pressure of oxygen)

    Time frame: 1 week

    PaO2 measurement using gasometry and osmometry methods. The sample is taken from 3 mL of arterial blood from arterial catheter from baseline (1 hour before first intervention) and 1 hour after intervention. PaO2 will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.

  20. Mean Arterial Pressure (MAP)

    Time frame: 1 week

    Mean Arterial Pressure is calculated using the MAP formula (Systole + 2 x diastole) / 3

  21. Heart Rate

    Time frame: 1 week

    Heart rate measured manually from the left radial artery for 1 minute

  22. Vasoactive Drugs needed

    Time frame: 1 week

    Highest dosage of vasoactive drugs during the intervention

  23. Mortality

    Time frame: 30 days

    Data extracted from medical record

  24. Length of Stay in ICU

    Time frame: 30 days

    Length of ICU stay in days from admission until the patient meets the ICU discharge criteria

  25. Length of Stay in Hospital

    Time frame: 30 days

    Length of hospital stay in days from admission until the patient discharged from the hospital

  26. Post ICU Routine Hemodialysis Need

    Time frame: 30 days

    Data extracted from medical record

  27. Fluid Status

    Time frame: 1 - 2 week

    Fluid Status was measured using Bioelectrical Impedance Analysis. The fluid status is represented from Extracellular Water (ECW), Intracellular Water (ICW), and Total Body Water (TBW). Measurements are conducted 1 hour Pre and Post Hemodialysis 1, 2, and 3.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Filter Hemodialysis in Reducing Inflammatory Mediators in Renal Dysfunction Due to Sepsis

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 12, 2023
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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