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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941624
• Other study ID #: IndonesiaUAnes043
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: Indonesia University
• Contact: Dita Aditianingsih, M.D.
• Phone: +628151819244
• Email: ditaaditiaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis
• Renal Dysfunction
• Renal Insufficiency
• Sepsis

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (29)

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Coudroy R, Payen D, Launey Y, Lukaszewicz AC, Kaaki M, Veber B, Collange O, Dewitte A, Martin-Lefevre L, Jabaudon M, Kerforne T, Ferrandiere M, Kipnis E, Vela C, Chevalier S, Mallat J, Charreau S, Lecron JC, Robert R; ABDOMIX group. Modulation by Polymyxin-B Hemoperfusion of Inflammatory Response Related to Severe Peritonitis. Shock. 2017 Jan;47(1):93-99. doi: 10.1097/SHK.0000000000000725. — View Citation

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. — View Citation

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. — View Citation

Hu XB, Gao HB, Liao ME, He MR. [The use of HA330-II microporous resin plasma adsorption in the treatment of chronic severe hepatitis]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2007 Dec;19(12):760-1. No abstract available. Chinese. — View Citation

Huang Z, Wang SR, Su W, Liu JY. Removal of humoral mediators and the effect on the survival of septic patients by hemoperfusion with neutral microporous resin column. Ther Apher Dial. 2010 Dec;14(6):596-602. doi: 10.1111/j.1744-9987.2010.00825.x. — View Citation

Kacar CK, Uzundere O, Kandemir D, Yektas A. Efficacy of HA330 Hemoperfusion Adsorbent in Patients Followed in the Intensive Care Unit for Septic Shock and Acute Kidney Injury and Treated with Continuous Venovenous Hemodiafiltration as Renal Replacement Therapy. Blood Purif. 2020;49(4):448-456. doi: 10.1159/000505565. Epub 2020 Jan 28. — View Citation

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. — View Citation

Li J, Li H, Deng W, Meng L, Gong W, Yao H. The Effect of Combination Use of Hemodialysis and Hemoperfusion on Microinflammation in Elderly Patients with Maintenance Hemodialysis. Blood Purif. 2022;51(9):739-746. doi: 10.1159/000518857. Epub 2022 Jan 14. — View Citation

Megha KB, Joseph X, Akhil V, Mohanan PV. Cascade of immune mechanism and consequences of inflammatory disorders. Phytomedicine. 2021 Oct;91:153712. doi: 10.1016/j.phymed.2021.153712. Epub 2021 Aug 19. — View Citation

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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. — View Citation

Peerapornratana S, Manrique-Caballero CL, Gomez H, Kellum JA. Acute kidney injury from sepsis: current concepts, epidemiology, pathophysiology, prevention and treatment. Kidney Int. 2019 Nov;96(5):1083-1099. doi: 10.1016/j.kint.2019.05.026. Epub 2019 Jun 7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sun S, He L, Bai M, Liu H, Li Y, Li L, Yu Y, Shou M, Jing R, Zhao L, Huang C, Wang H. High-volume hemofiltration plus hemoperfusion for hyperlipidemic severe acute pancreatitis: a controlled pilot study. Ann Saudi Med. 2015 Sep-Oct;35(5):352-8. doi: 10.5144/0256-4947.2015.352. — View Citation

Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. doi: 10 — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	Glomerular Filtration Rate (GFR)	Glomerular Filtration Rate measurement with creatinine clearance test using the Cockcroft-Gault formula	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	Mean Arterial Pressure (MAP)	Mean Arterial Pressure is calculated using the MAP formula (Systole + 2 x diastole) / 3	1 week
Secondary	Heart Rate	Heart rate measured manually from the left radial artery for 1 minute	1 week
Secondary	Vasoactive Drugs needed	Highest dosage of vasoactive drugs during the intervention	1 week
Secondary	Mortality	Data extracted from medical record	30 days
Secondary	Length of Stay in ICU	Length of ICU stay in days from admission until the patient meets the ICU discharge criteria	30 days
Secondary	Length of Stay in Hospital	Length of hospital stay in days from admission until the patient discharged from the hospital	30 days
Secondary	Post ICU Routine Hemodialysis Need	Data extracted from medical record	30 days
Secondary	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.	1 - 2 week