Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Hemodialysis Filter
- Conditions
- HemodialysisRenal DysfunctionSepsis
- Interventions
- Device: Ha-330 Hemoperfusion Filter HemodialysisDevice: Conventional Hemodialysis
- Registration Number
- NCT05941624
- Lead Sponsor
- Indonesia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- Patients with hemodynamic instability who need norepinephrine more than 0.5 microgram/kg/minute
- Patients denied to be included in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ha-330 Hemoperfusion Filter Hemodialysis Ha-330 Hemoperfusion Filter Hemodialysis Participants underwent therapy using Ha-330 Hemoperfusion Filter Hemodialysis for 4 hours, 3 times a week, with two days apart between dialysis. Conventional hemodialysis Conventional Hemodialysis Participants underwent therapy using Conventional Hemodialysis for 4 hours, 3 times a week, with two days apart between dialysis.
- Primary Outcome Measures
Name Time Method Change in Interleukin (IL)-1Ra concentration before and after hemodialysis 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 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 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 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 Outcome Measures
Name Time Method Post ICU Routine Hemodialysis Need 30 days Data extracted from medical record
Bilirubin Levels 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.
Blood pH (Potential Hydrogen) 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.
Neutrophils Levels 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.
Procalcitonin Levels 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.
Serum Glutamic Pyruvate Transaminase (SGPT) Levels 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.
International Normalizing Ratio (INR) 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.
Leukocytes Levels 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.
Lymphocytes Levels 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.
Thrombocytes Levels 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.
Urea Levels 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.
Creatinine Levels 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.
Lactate Levels 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.
C-Reactive Protein (CRP) Levels 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.
Glomerular Filtration Rate (GFR) 1 week Glomerular Filtration Rate measurement with creatinine clearance test using the Cockcroft-Gault formula
Serum Glutamic Oxaloacetic Transaminase (SGOT) Levels 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.
Prothrombin Time (PT) 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.
Activated Partial Thromboplastin Time (aPTT) 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.
Base Excess (BE) 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.
PaO2 (Partial pressure of oxygen) 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.
Heart Rate 1 week Heart rate measured manually from the left radial artery for 1 minute
Mean Arterial Pressure (MAP) 1 week Mean Arterial Pressure is calculated using the MAP formula (Systole + 2 x diastole) / 3
Vasoactive Drugs needed 1 week Highest dosage of vasoactive drugs during the intervention
Mortality 30 days Data extracted from medical record
Length of Stay in ICU 30 days Length of ICU stay in days from admission until the patient meets the ICU discharge criteria
Length of Stay in Hospital 30 days Length of hospital stay in days from admission until the patient discharged from the hospital
Fluid Status 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.
Trial Locations
- Locations (1)
Cipto Mangunkusumo Hospital
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia