Clinical trial NCT05941624: Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Hemodialysis Filter
Official title: Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Filter Hemodialysis in Reducing Inflammatory Mediators in Renal Dysfunction Due to Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dysfunction
Sepsis
Hemodialysis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Interleukin (IL)-1Ra concentration before and after hemodialysis
timeFrame: 1 week
measure: Change in Interleukin (IL)-6 concentration before and after hemodialysis
timeFrame: 1 week
measure: Change in Interleukin (IL)-10 concentration before and after hemodialysis
timeFrame: 1 week
measure: Change in Tumor Necrosis Factor (TNF)-a concentration before and after hemodialysis
timeFrame: 1 week
Secondary outcomes:
measure: Leukocytes Levels
timeFrame: 1 week
measure: Neutrophils Levels
timeFrame: 1 week
measure: Lymphocytes Levels
timeFrame: 1 week
measure: Thrombocytes Levels
timeFrame: 1 week
measure: C-Reactive Protein (CRP) Levels
timeFrame: 1 week
measure: Procalcitonin Levels
timeFrame: 1 week
measure: Urea Levels
timeFrame: 1 week
measure: Creatinine Levels
timeFrame: 1 week
measure: Glomerular Filtration Rate (GFR)
timeFrame: 1 week
measure: Bilirubin Levels
timeFrame: 1 week
measure: Serum Glutamic Oxaloacetic Transaminase (SGOT) Levels
timeFrame: 1 week
measure: Serum Glutamic Pyruvate Transaminase (SGPT) Levels
timeFrame: 1 week
measure: Prothrombin Time (PT)
timeFrame: 1 week
measure: Activated Partial Thromboplastin Time (aPTT)
timeFrame: 1 week
measure: International Normalizing Ratio (INR)
timeFrame: 1 week
measure: Lactate Levels
timeFrame: 1 week
measure: Blood pH (Potential Hydrogen)
timeFrame: 1 week
measure: Base Excess (BE)
timeFrame: 1 week
measure: PaO2 (Partial pressure of oxygen)
timeFrame: 1 week
measure: Mean Arterial Pressure (MAP)
timeFrame: 1 week
measure: Heart Rate
timeFrame: 1 week
measure: Vasoactive Drugs needed
timeFrame: 1 week
measure: Mortality
timeFrame: 30 days
measure: Length of Stay in ICU
timeFrame: 30 days
measure: Length of Stay in Hospital
timeFrame: 30 days
measure: Post ICU Routine Hemodialysis Need
timeFrame: 30 days
measure: Fluid Status
timeFrame: 1 - 2 week
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dita Aditianingsih, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.2215/CJN.00710113. Epub 2013 Jun 6.
citation: 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.
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.
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.
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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
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.
citation: 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.
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.
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.
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.
citation: 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.
citation: Chua HR, Wong WK, Ong VH, Agrawal D, Vathsala A, Tay HM, Mukhopadhyay A. Extended Mortality and Chronic Kidney Disease After Septic Acute Kidney Injury. J Intensive Care Med. 2020 Jun;35(6):527-535. doi: 10.1177/0885066618764617. Epub 2018 Mar 18.
citation: Zarjou A, Agarwal A. Sepsis and acute kidney injury. J Am Soc Nephrol. 2011 Jun;22(6):999-1006. doi: 10.1681/ASN.2010050484. Epub 2011 May 12.
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.
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.
citation: Mishra SB, Singh RK, Baronia AK, Poddar B, Azim A, Gurjar M. Sustained low-efficiency dialysis in septic shock: Hemodynamic tolerability and efficacy. Indian J Crit Care Med. 2016 Dec;20(12):701-707. doi: 10.4103/0972-5229.195704.
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.
citation: Bagshaw SM, Berthiaume LR, Delaney A, Bellomo R. Continuous versus intermittent renal replacement therapy for critically ill patients with acute kidney injury: a meta-analysis. Crit Care Med. 2008 Feb;36(2):610-7. doi: 10.1097/01.CCM.0B013E3181611F552.
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.
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.
citation: Bai M, Yu Y, Huang C, Liu Y, Zhou M, Li Y, Ma F, Jing R, Zhao L, Li L, Wang P, He L, Sun S. Continuous venovenous hemofiltration combined with hemoperfusion for toxic epidermal necrolysis: a retrospective cohort study. J Dermatolog Treat. 2017 Jun;28(4):353-359. doi: 10.1080/09546634.2016.1240326. Epub 2016 Oct 24.
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.
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.
citation: 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.