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IRCT201507069045N3 IRCT 2016-04-03 Vice Chancellor for research , Tehran University of Medical Sciences Role of early hemodialysis on acute kidney injury in critically ill patients Role of early hemodialysis on acute kidney injury in critically ill patients at Tehran Imam Khomeini Hospital 2015-09-23 anticipated 60 Complete https://irct.ir/trial/9679 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Acute renal injury. Intervention 1: For early Hemodialysis Group (D) , central vein catheter will be inserted for the patients and dialysis will start daily ( 2 hours for the first day then 4 hours). Dialysis will be done at least for 3 days and in case of appropriate urination , correction of urea or creatinine, dialysis implementation will be every other day for about 3 hours. When the blood urea and creatinine are stabled, the dialysis is suspended and restarting is according to mentioned indications.Solution for the hemodialysis: acidic hemodialysis concentrated 2.4920 ml.The solution must be diluted 35 times immediately before use.For this purpose ,add 1 liter of concentrated solution to 34 liter pure water.In case of turbid liquid or particles ,it is not usable.After use,the remaining solution must be discarded.Sodium bicarbonate will be added immediately before use.This solution contains: sodium chloride,potassium chloride, magnesium chloride,calcium chloride,glacial acetic acid,dextrose.Electrolytes are: sodium, potassium, magnesium, calcium, chloride, acetate.Maintanance condition: the solution must be away from light and kept under 30 c and protected from freezing.It is a product of Faran pharmaceutical chemical company,Tuyserkan,Iran. Intervention 2: Control group: in case of oliguria (U/O<0.5 ml/kg/h) or aniria (U/O<0.3 ml/kg/h or cessation of urine ) , infusion of 500 ml crystalloid with 60 mg Furosemide in 1 hour will be administered and while there is no response , the patient entered the study and hemodialysis will started after inserting central vein catheter . Solution for the hemodialysis: acidic hemodialysis concentrated 2.4920 ml.The solution must be diluted 35 times immediately before use.For this purpose ,add 1 liter of concentrated solution to 34 liter pure water.In case of turbid liquid or particles ,it is not usable.After use,the remaining solution must be discarded.Sodium bicarbonate will be added immediately before use.This solution contains: sodium chloride,potassium chloride, magnesium chloride,calcium chloride,glacial acetic acid,dextrose.Electrolytes are: sodium, potassium, magnesium, calcium, chloride, acetate.Maintanance condition: the solution must be away from light and kept under 30 c and protected from freezing.It is a product of Faran pharmaceutical chemical company,Tuyserkan,Iran.
public Mohammad Taghi Beigmohammadi.MD
Cancer institute , Imam Khomeini hospital, Keshavarz boulevard, Tehran
Tehran Iran (Islamic Republic of) +98 21 6119 2511 mbage46@gmail.com; beigmohammadi@tums.ac.ir Imam Khomeini Hospital Complex scientific Mohammad Taghi Beigmohammadi.MD
Cancer institute, Imam Khomeini Hospital , Keshavarz boulevard , Tehran
Tehran Iran (Islamic Republic of) +98 21 6119 2511 mbage46@gmail.com; beigmohammadi@tums.ac.ir Imam Khomeini Hospital Complex Iran (Islamic Republic of) Inclusion criteria: if there is one of the following scales such as ; at least 50% creatinine rise from the admission time ; BUN>70 ; oliguria <0.5 ml/kg/h for 12 hours with no response to volume and Furosemide ; anuria <0.3 ml/kg/h for 6 hours with no response to volume and Furosemide; will be specified as Early Hemodialysis Group (D) and if there is criteria such as volume overload ( pulmonary edema) ; BUN>100 or occurance of azotemia complications ( ex:loss of Consciousness ) and cr>4 will be specified as Group C. In case of oliguria (U/O<0.5 ml/kg/h) or aniria (U/O<0.3 ml/kg/h or cessation of urine ) , infusion of 500 ml crystalloid with 60 mg Furosemide in 1 hour will be administered and while there is no response , the patient entered the study; Exclusion criteria: history of renal insufficiency ; reception of high dose inotropics; septic shock ; severe electrolyte abnormalities leading to hemodialysis. 18 years 60 years Both Treatment - Other Treatment - Other For early Hemodialysis Group (D) , central vein catheter will be inserted for the patients and dialysis will start daily ( 2 hours for the first day then 4 hours). Dialysis will be done at least for 3 days and in case of appropriate urination , correction of urea or creatinine, dialysis implementation will be every other day for about 3 hours. When the blood urea and creatinine are stabled, the dialysis is suspended and restarting is according to mentioned indications.Solution for the hemodialysis: acidic hemodialysis concentrated 2.4920 ml.The solution must be diluted 35 times immediately before use.For this purpose ,add 1 liter of concentrated solution to 34 liter pure water.In case of turbid liquid or particles ,it is not usable.After use,the remaining solution must be discarded.Sodium bicarbonate will be added immediately before use.This solution contains: sodium chloride,potassium chloride, magnesium chloride,calcium chloride,glacial acetic acid,dextrose.Electrolytes are: sodium, potassium, magnesium, calcium, chloride, acetate.Maintanance condition: the solution must be away from light and kept under 30 c and protected from freezing.It is a product of Faran pharmaceutical chemical company,Tuyserkan,Iran. Control group: in case of oliguria (U/O<0.5 ml/kg/h) or aniria (U/O<0.3 ml/kg/h or cessation of urine ) , infusion of 500 ml crystalloid with 60 mg Furosemide in 1 hour will be administered and while there is no response , the patient entered the study and hemodialysis will started after inserting central vein catheter . Solution for the hemodialysis: acidic hemodialysis concentrated 2.4920 ml.The solution must be diluted 35 times immediately before use.For this purpose ,add 1 liter of concentrated solution to 34 liter pure water.In case of turbid liquid or particles ,it is not usable.After use,the remaining solution must be discarded.Sodium bicarbonate will be added immediately before use.This solution contains: sodium chloride,potassium chloride, magnesium chloride,calcium chloride,glacial acetic acid,dextrose.Electrolytes are: sodium, potassium, magnesium, calcium, chloride, acetate.Maintanance condition: the solution must be away from light and kept under 30 c and protected from freezing.It is a product of Faran pharmaceutical chemical company,Tuyserkan,Iran. Blood urea. Timepoint: Before intervention, daily after intervention. Method of measurement: Blood sample. Plasma creatinine. Timepoint: Before intervention, daily after intervention. Method of measurement: Blood sample. Urine volume. Timepoint: Before intervention, daily after intervention. Method of measurement: Fully catheter and urine bag. Length of stay in intensive care unit. Timepoint: Daily. Method of measurement: Number of admission days in intensive care unit. Mortality rate in intensive care unit. Timepoint: Daily. Method of measurement: Rate of 28-day mortality. Vice Chancellor for research , Tehran University of Medical Sciences Approved 2015-07-05 Ethics Committee of Tehran University of Medical Sciences Keshavarz Boulevard,Amir Abad, Tehran Tehran Iran (Islamic Republic of)