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IRCT20221108056446N4 IRCT 2023-11-15 Esfahan University of Medical Sciences Acetazolamide and Topiramate on patients with traumatic cerebrospinal fluid leakage Comparing the effect of Acetazolamide and Topiramate on patients with traumatic cerebrospinal fluid leakage 2022-12-22 anticipated 120 Complete https://irct.ir/trial/73228 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People are placed in 2 groups by random block method. In this way, the first 2 eligible people are selected and after obtaining consent, they enter to participate in the study. These 2 people are considered as a block of 2 and are sorted according to the last digit of the national code. The treatment methods are specified as A, B, and all combinations of 2 are specified, and after the last surgery, decoding is done for the last block. 2 Brain Trauma. Intervention 1: Intervention group: They receive 1 gram of acetazolamide in oral form every 24 hours, which will continue for 5-7 days. Intervention 2: Control group: They receive 100 mg topiramate orally every 24 hours, which will continue for 5-7 days. 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 Mehdi Mahmoodkhani
Kashani street
Esfahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 mahmoodkhani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehdi Mahmoodkhani
Kashani street
Esfahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 mahmoodkhani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient consent to enter the study The patient's non-use of Tricyclic Antidepressants and carbonic anhydrase inhibitor in order to prevent drug interactions. no limit no limit Both Patients who develop meningitis and brain abscess Patients with severe electrolyte disturbances Patients who do not respond to treatment and have to use brain surgery Patients who did not respond to drug therapy after one week and another intervention should be performed on them Failure to visit the patient for follow-up Kidney and liver patients who are suffering from a specific disease based on the diagnosis of a specialist and are listed in the patient's medical record S06.2 Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: They receive 1 gram of acetazolamide in oral form every 24 hours, which will continue for 5-7 days Control group: They receive 100 mg topiramate orally every 24 hours, which will continue for 5-7 days. Cerebrospinal fluid leakage. Timepoint: Patients are evaluated weekly using a checklist and up to three months after discharge from the hospital. Method of measurement: Checklist and measurement of GCS. Esfahan University of Medical Sciences Approved 2023-08-14 Isfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)