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IRCT20181108041595N1 IRCT 2019-11-23 Shahid Beheshti University of Medical Sciences The effect of Bio-impedance Analysis in fluid management of patients on Continuous Renal Replacement Therapy Clinical evaluation of applying bio-impedance analysis as a guide to detect the appropriate ultrafiltration rate in patients undergoing continuous renal replacement therapy 2018-04-19 anticipated 65 Complete https://irct.ir/trial/40793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible patients admitted to the ICU during the study period are included. The method of randomization is simple and patients are assigned to case or control groups by using a software generated table of random numbers. Bio-impedance analysis is performed for all participant by the operator every 8 hours during performing CRRT. In order to carry out allocation concealment, the patient code is sent to a third party who has the table of random number to decide whether this code directs patient to the study or control group. Then he inform the principal investigator about the patient group. The investigator will apply the results of bio-impedance analysis in determining UF volume during CRRT only in case group, Blinding description: Bio-impedance analysis is performed for all patients and our participants or their guardians are not awarded of the study group they are assigned to. Our data analyzer will analyze the data of two groups without having any other information about the aim of the study and case or control groups. In the study design, the results of bio-impedance analysis should be consider in the order of ultrafiltration volume is only in participants directed to study group. So, the main investigator can not be blinded. N/A Condition 1: AKI- increase in serum creatinine by at least 0.3 mg/dl within 48 hours or 1.5 times baseline within prior 7 days or urine volume less than 0.5 ml/kg/hour for six hours. Condition 2: Fluid overload:excess fluid in intracellular or extracellular compartments. Intervention 1: Intervention group: In patients of this group the volume of fluid removal with ultrafiltration during CRRT is determined based on the results of bio-impedance analysis. Intervention 2: Control group: In patients of this group the volume of fluid removal with ultrafiltration during CRRT is determined based on clinical findings. Yes - There is a plan to make this available What will be shared: All individual non-identified participant data When: 6 months after publication To whom: For people working in academic institutions Conditions: Further sharing of the data should be with permission of original investigators The use of data for purposes other than those originally proposed in the application is prohibited Where to obtain: The applicants can get the documents through the email, f_rashid@sbmu.ac.ir How to obtain: The process of evaluating the requests and sending these documents will take about 3 months. Comments:
public Farin Rashid Farokhi
5th west, 8, Ghobadian st., Alborz st., Mirdamad blv
Tehran Iran (Islamic Republic of) 1918933698 +98 21 2291 5028 f_rashid@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Farin Rashid Farokhi
5th west, 8, Ghobadian st., Alborz st., Mirdamad blv
Tehran Iran (Islamic Republic of) 1918933698 +98 21 2291 5028 f_rashid@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Admission to the intensive care units of Masih Daneshvari Hospital during the study period Occurring of acute kidney injury Requirement of continuous Renal Replacement Therapy Age of more than 18 years 18 years no limit Both History of of stage 4 and 5 of chronic kidney disease History of kidney transplantation Cardiorespiratory resuscitation within 24 hours before the start of Renal Replacement Therapy Patient death before 24 hours of starting first Continuous Renal Replacement Therapy History of limb amputation N17-N19 E87.7 Acute kidney failure Fluid overload Treatment - Devices Placebo Intervention group: In patients of this group the volume of fluid removal with ultrafiltration during CRRT is determined based on the results of bio-impedance analysis. Control group: In patients of this group the volume of fluid removal with ultrafiltration during CRRT is determined based on clinical findings. The water content lean body mass. Timepoint: After 72 hours of undergoing CRRT with excluding the time in interruption periods between CRRT sessions. Method of measurement: Records of bioimpedance analyser instrument. Duration of ICU admission. Timepoint: After discharge from the hospital. Method of measurement: Patient's medical files. Duration of hospital admission. Timepoint: After discharge from the hospital. Method of measurement: Patient's medical files. Time duration of spending under mechanical ventilation. Timepoint: After discharge from the hospital. Method of measurement: Patient's medical files. Urine output. Timepoint: every 8 hors during CRRT. Method of measurement: use of scaled containers. Mortality rate. Timepoint: At 10th , 30th and 60th day of the study. Method of measurement: Patient are followed for mortality up to 60 days . At the 10th , 30th and 6th day , the mortality is recorded. Shahid Beheshti University of Medical Sciences Approved 2018-04-17 Ethics committee of Shahid Beheshti University of Medical Science SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)