Comparative study of aminophylline infusion with dopamine infusion in traumatic brain injury patients with renal impairment

The present study aims to compare the efficacy of aminophylline infusion with dopamine infusion in patients with renal dysfunction caused by traumatic brain injury.

This study is a blinded clinical trial and will be conducted in parallel and by comparing three types of pharmacotherapy regimes on 60 patients with TBI induced Acute kidney injury in Al-Zahra and Kashani Medical Centers in Isfahan .Patients were randomly divided into three groups using Excel software with random function.

The present double-blind randomized clinical trial will be conducted at Kashani Training Hospital to compare the clinical effects of dopamine and aminophylline in the treatment of acute kidney injury (AKI) secondary to traumatic brain injury (TBI). The study will be conducted in three groups: aminophylline, dopamine, and placebo. Patients will be randomly assigned to treatment groups. It should be mentioned that patients and examiners will be blinded to the type of intervention.

Inclusion criteria: Patients with traumatic brain injury; aged 18 to 65 years; admitted to the intensive care unit (ICU) due to acute kidney injury (AKI) secondary to trauma; informed consent obtained from patient or legally authorized representative (LAR)

In the first group, aminophylline will be administered by intravenous infusion at a dose of 0.2 mg/kg/h. In the second group, dopamine will be administered by intravenous infusion at a dose of 2 μg/kg/min. In the third group (control group), placebo (normal saline) will be administered by intravenous infusion at a dose of 0%/9.

Urine output, serum BUN, and creatinine will be measured in patients for 24 hours from the start of the intervention.

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.

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.