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IRCT20221108056446N8 IRCT 2024-05-25 Esfahan University of Medical Sciences Comparison of aminophylline infusion with dopamine infusion in patients with kidney dysfunction caused by traumatic brain injuries. Comparative study of aminophylline infusion with dopamine infusion in traumatic brain injury patients with renal impairment 2024-06-11 anticipated 60 Complete https://irct.ir/trial/76715 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient are placed in three groups by random block method. With the easy sampling method, the referring people who are eligible to enter the study are randomly divided into three groups. In this study, the classification of people is done by the four permutation block method. In this method, A represents a person who undergoes surgery with a routine method, and B represents a person who undergoes surgery with a new method. Considering the block of three, we give code 0 to ABC permutation, code 1 to BAC permutation, code 2 to CBA, code 3 to CAB, code 4 to ACB and code 5 to BCA. Then, using the table of random numbers, we randomly select a starting point and then consider the numbers in rows or columns. Considering the order of the numbers in the table, we place the corresponding permutation on each number we come across, Blinding description: Patients and physicians were unaware of the intervention group and the drugs were pre-prepared and will be injected into patients based on labels A, B, C. It should be noted that patient data will also be recorded based on their intervention label. N/A Condition 1: Acute kidney injury. Condition 2: Traumatic brain injury. Intervention 1: Intervention group 1: Receive aminophylline at a dose of 0.2 mg/kg/h. Intervention 2: Intervention group 2: Receive dopamine at a dose of 2 μg/kg/min. Intervention 3: Control group: Receive normal saline. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Seyed Taghi Hashemi
kashani street
Isfahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 st_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Seyed Taghi Hashem
Kashani street
Isfahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 st_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Confirmed Traumatic brain injury by neurological surgeon TBI induced acute kidney injury 18 years 65 years Both Hemodynamic instability Contraindication for of aminophylline or dopamine administration N17.0 S06.2X Acute kidney injury Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Receive aminophylline at a dose of 0.2 mg/kg/h Intervention group 2: Receive dopamine at a dose of 2 μg/kg/min Control group: Receive normal saline Urinary output. Timepoint: 24 hours after injection. Method of measurement: Urine collection. BUN level. Timepoint: 24 hours after injection. Method of measurement: Blood test. Esfahan University of Medical Sciences Approved 2023-09-25 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)