Renal DysfunctionNCT05941624

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

A study testing Ha-330 Hemoperfusion Filter Hemodialysis and Conventional Hemodialysis in people with Renal Dysfunction and Sepsis, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Renal Dysfunction, Sepsis, Hemodialysis
What is being tested?: Ha-330 Hemoperfusion Filter Hemodialysis and Conventional Hemodialysis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteIndonesia
Study dates: 16 Jun 2023to 31 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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

Read the detailed 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.

Conditions: Renal Dysfunction, Sepsis, Hemodialysis
Being tested: Ha-330 Hemoperfusion Filter Hemodialysis, Conventional Hemodialysis
Medical subject headings: Renal Insufficiency, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ha-330 Hemoperfusion Filter HemodialysisDevice
a total of 4 hours therapy, 3 times a week. Each therapy should be two days apart
Conventional HemodialysisDevice
a total of 4 hours therapy, 3 times a week. Each therapy should be two days apart

Study groups in NCT05941624
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Conventional Hemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week

Secondary outcomes (27)

Leukocytes Levels
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.
Measured: 1 week
Neutrophils Levels
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.
Measured: 1 week
Lymphocytes Levels
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.
Measured: 1 week
Thrombocytes Levels
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.
Measured: 1 week
C-Reactive Protein (CRP) Levels
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.
Measured: 1 week
Procalcitonin Levels
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.
Measured: 1 week
Urea Levels
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.
Measured: 1 week
Creatinine Levels
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.
Measured: 1 week
Glomerular Filtration Rate (GFR)
Glomerular Filtration Rate measurement with creatinine clearance test using the Cockcroft-Gault formula
Measured: 1 week
Bilirubin Levels
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.
Measured: 1 week
Serum Glutamic Oxaloacetic Transaminase (SGOT) Levels
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.
Measured: 1 week
Serum Glutamic Pyruvate Transaminase (SGPT) Levels
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.
Measured: 1 week
Prothrombin Time (PT)
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.
Measured: 1 week
Activated Partial Thromboplastin Time (aPTT)
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.
Measured: 1 week
International Normalizing Ratio (INR)
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.
Measured: 1 week
Lactate Levels
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.
Measured: 1 week
Blood pH (Potential Hydrogen)
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.
Measured: 1 week
Base Excess (BE)
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.
Measured: 1 week
PaO2 (Partial pressure of oxygen)
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.
Measured: 1 week
Mean Arterial Pressure (MAP)
Mean Arterial Pressure is calculated using the MAP formula (Systole + 2 x diastole) / 3
Measured: 1 week
Heart Rate
Heart rate measured manually from the left radial artery for 1 minute
Measured: 1 week
Vasoactive Drugs needed
Highest dosage of vasoactive drugs during the intervention
Measured: 1 week
Mortality
Data extracted from medical record
Measured: 30 days
Length of Stay in ICU
Length of ICU stay in days from admission until the patient meets the ICU discharge criteria
Measured: 30 days
Length of Stay in Hospital
Length of hospital stay in days from admission until the patient discharged from the hospital
Measured: 30 days
Post ICU Routine Hemodialysis Need
Data extracted from medical record
Measured: 30 days
Fluid Status
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.
Measured: 1 - 2 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 202331 Mar 2024

First posted12 Jul 2023
Study start16 Jun 2023
Primary completion31 Dec 2023
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Renal DysfunctionStudies of the same condition, open and under way.
More trials run by Universitas IndonesiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05941624
Sponsor's protocol ID: IndonesiaUAnes043
Status last verified: May 2025
First submitted: 20 Jun 2023
Last updated: 2 May 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
PubMed 16106006
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
PubMed 22890468
Ronco C, Ricci Z, De Backer D, Kellum JA, Taccone FS, Joannidis M, Pickkers P, Cantaluppi V, Turani F, Saudan P, Bellomo R, Joannes-Boyau O, Antonelli M, Payen D, Prowle JR, Vincent JL. Renal replacement therapy in acute kidney injury: controversy and consensus. Crit Care. 2015 Apr 6;19(1):146. doi: 10.1186/s13054-015-0850-8.
PubMed 25887923
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691
Ahmed AR, Obilana A, Lappin D. Renal Replacement Therapy in the Critical Care Setting. Crit Care Res Pract. 2019 Jul 16;2019:6948710. doi: 10.1155/2019/6948710. eCollection 2019.
PubMed 31396416
Ankawi G, Fan W, Pomare Montin D, Lorenzin A, Neri M, Caprara C, de Cal M, Ronco C. A New Series of Sorbent Devices for Multiple Clinical Purposes: Current Evidence and Future Directions. Blood Purif. 2019;47(1-3):94-100. doi: 10.1159/000493523. Epub 2018 Sep 25.
PubMed 30253409
Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
PubMed 31954465
Chousterman BG, Swirski FK, Weber GF. Cytokine storm and sepsis disease pathogenesis. Semin Immunopathol. 2017 Jul;39(5):517-528. doi: 10.1007/s00281-017-0639-8. Epub 2017 May 29.
PubMed 28555385
Murugan R, Karajala-Subramanyam V, Lee M, Yende S, Kong L, Carter M, Angus DC, Kellum JA; Genetic and Inflammatory Markers of Sepsis (GenIMS) Investigators. Acute kidney injury in non-severe pneumonia is associated with an increased immune response and lower survival. Kidney Int. 2010 Mar;77(6):527-35. doi: 10.1038/ki.2009.502. Epub 2009 Dec 23.
PubMed 20032961
Fiorentino M, Tohme FA, Wang S, Murugan R, Angus DC, Kellum JA. Long-term survival in patients with septic acute kidney injury is strongly influenced by renal recovery. PLoS One. 2018 Jun 5;13(6):e0198269. doi: 10.1371/journal.pone.0198269. eCollection 2018.
PubMed 29870535
Alobaidi R, Basu RK, Goldstein SL, Bagshaw SM. Sepsis-associated acute kidney injury. Semin Nephrol. 2015 Jan;35(1):2-11. doi: 10.1016/j.semnephrol.2015.01.002.
PubMed 25795495
Schneider AG, Bellomo R, Bagshaw SM, Glassford NJ, Lo S, Jun M, Cass A, Gallagher M. Choice of renal replacement therapy modality and dialysis dependence after acute kidney injury: a systematic review and meta-analysis. Intensive Care Med. 2013 Jun;39(6):987-97. doi: 10.1007/s00134-013-2864-5. Epub 2013 Feb 27.
PubMed 23443311
Sood MM, Shafer LA, Ho J, Reslerova M, Martinka G, Keenan S, Dial S, Wood G, Rigatto C, Kumar A; Cooperative Antimicrobial Therapy in Septic Shock (CATSS) Database Research Group. Early reversible acute kidney injury is associated with improved survival in septic shock. J Crit Care. 2014 Oct;29(5):711-7. doi: 10.1016/j.jcrc.2014.04.003. Epub 2014 Apr 18.
PubMed 24927984
See EJ, Jayasinghe K, Glassford N, Bailey M, Johnson DW, Polkinghorne KR, Toussaint ND, Bellomo R. Long-term risk of adverse outcomes after acute kidney injury: a systematic review and meta-analysis of cohort studies using consensus definitions of exposure. Kidney Int. 2019 Jan;95(1):160-172. doi: 10.1016/j.kint.2018.08.036. Epub 2018 Nov 23.
PubMed 30473140
Chawla LS, Amdur RL, Amodeo S, Kimmel PL, Palant CE. The severity of acute kidney injury predicts progression to chronic kidney disease. Kidney Int. 2011 Jun;79(12):1361-9. doi: 10.1038/ki.2011.42. Epub 2011 Mar 23.
PubMed 21430640

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Filter Hemodialysis in Reducing Inflammatory Mediators in Renal Dysfunction Due to Sepsis
ClinicalTrials.gov ID: NCT05941624
Acronym / sponsor ID: IndonesiaUAnes043
Conditions: Renal Dysfunction, Sepsis, Hemodialysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Study start: 16 Jun 2023 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 12 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ha-330 Hemoperfusion Filter Hemodialysis	Experimental	Device: Ha-330 Hemoperfusion Filter HemodialysisParticipants underwent therapy using Ha-330 Hemoperfusion Filter Hemodialysis for 4 hours, 3 times a week, with two days apart between dialysis.
Conventional hemodialysis	Active comparator	Device: Conventional HemodialysisParticipants underwent therapy using Conventional Hemodialysis for 4 hours, 3 times a week, with two days apart between dialysis.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ha-330 Hemoperfusion Filter Hemodialysisa total of 4 hours therapy, 3 times a week. Each therapy should be two days apart	Device	Ha-330 Hemoperfusion Filter Hemodialysis
Conventional Hemodialysisa total of 4 hours therapy, 3 times a week. Each therapy should be two days apart	Device	Conventional hemodialysis

Primary outcome

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.
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.
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.
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.

27 secondary outcomes

Leukocytes Levels
Time frame: 1 week
Neutrophils Levels
Time frame: 1 week
Lymphocytes Levels
Time frame: 1 week
Thrombocytes Levels
Time frame: 1 week
C-Reactive Protein (CRP) Levels
Time frame: 1 week
Procalcitonin Levels
Time frame: 1 week
Urea Levels
Time frame: 1 week
Creatinine Levels
Time frame: 1 week
Glomerular Filtration Rate (GFR)
Time frame: 1 week
Bilirubin Levels
Time frame: 1 week
Serum Glutamic Oxaloacetic Transaminase (SGOT) Levels
Time frame: 1 week
Serum Glutamic Pyruvate Transaminase (SGPT) Levels
Time frame: 1 week
Prothrombin Time (PT)
Time frame: 1 week
Activated Partial Thromboplastin Time (aPTT)
Time frame: 1 week
International Normalizing Ratio (INR)
Time frame: 1 week
Lactate Levels
Time frame: 1 week
Blood pH (Potential Hydrogen)
Time frame: 1 week
Base Excess (BE)
Time frame: 1 week
PaO2 (Partial pressure of oxygen)
Time frame: 1 week
Mean Arterial Pressure (MAP)
Time frame: 1 week
Heart Rate
Time frame: 1 week
Vasoactive Drugs needed
Time frame: 1 week
Mortality
Time frame: 30 days
Length of Stay in ICU
Time frame: 30 days
Length of Stay in Hospital
Time frame: 30 days
Post ICU Routine Hemodialysis Need
Time frame: 30 days
Fluid Status
Time frame: 1 - 2 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Background: PubMed 16106006Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
Background: PubMed 22890468Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
Background: PubMed 25887923Ronco C, Ricci Z, De Backer D, Kellum JA, Taccone FS, Joannidis M, Pickkers P, Cantaluppi V, Turani F, Saudan P, Bellomo R, Joannes-Boyau O, Antonelli M, Payen D, Prowle JR, Vincent JL. Renal replacement therapy in acute kidney injury: controversy and consensus. Crit Care. 2015 Apr 6;19(1):146. doi: 10.1186/s13054-015-0850-8.
Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
Background: PubMed 31396416Ahmed AR, Obilana A, Lappin D. Renal Replacement Therapy in the Critical Care Setting. Crit Care Res Pract. 2019 Jul 16;2019:6948710. doi: 10.1155/2019/6948710. eCollection 2019.
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Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dita Aditianingsih, M.D. principal investigator

Universitas Indonesia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ha-330 Hemoperfusion Filter Hemodialysis and Conventional Hemodialysis in people with Renal Dysfunction and Sepsis, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Interleukin (IL)-1Ra concentration before and after hemodialysis (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05941624, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.