The purpose of this study is to compare the effectiveness between conventional hemodialysis and hemodialysis using hemoperfusion adsorbents in renal dysfunction caused by sepsis
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
a total of 4 hours therapy, 3 times a week. Each therapy should be two days apart
a total of 4 hours therapy, 3 times a week. Each therapy should be two days apart
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week
Glomerular Filtration Rate (GFR)
Glomerular Filtration Rate measurement with creatinine clearance test using the Cockcroft-Gault formula
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week
Mean Arterial Pressure (MAP)
Mean Arterial Pressure is calculated using the MAP formula (Systole + 2 x diastole) / 3
Time frame: 1 week
Heart Rate
Heart rate measured manually from the left radial artery for 1 minute
Time frame: 1 week
Vasoactive Drugs needed
Highest dosage of vasoactive drugs during the intervention
Time frame: 1 week
Mortality
Data extracted from medical record
Time frame: 30 days
Length of Stay in ICU
Length of ICU stay in days from admission until the patient meets the ICU discharge criteria
Time frame: 30 days
Length of Stay in Hospital
Length of hospital stay in days from admission until the patient discharged from the hospital
Time frame: 30 days
Post ICU Routine Hemodialysis Need
Data extracted from medical record
Time frame: 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.
Time frame: 1 - 2 week