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IRCT20210514051289N1 IRCT 2022-05-08 Esfahan University of Medical Sciences Effect of Angiotensin-converting enzyme and β-blockers on the prognosis of severe isolated brain trauma Effect of Angiotensin-converting enzyme and β-blockers on the prognosis of patients with severely isolated brain trauma 2021-11-22 anticipated 96 Complete https://irct.ir/trial/56391 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a double-blind clinical trial in which patients are randomly divided into three groups. Random function of Excel software based on patient file number will be used for randomization. Patients with severe trauma enter the Excel program based on the file number and were divided into - 2 groups case, and control group based on the random button. There were three groups of 32 people in total. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has three groups that can be numbered from 1 to 3, respectively. It is clear that the repetition of each number occurs once in each group, so select the repeating each number option and select 32 for repeating the sequence. In this way, 96 units will be produced, Blinding description: This study is a double-blind clinical trial in which patients are randomly divided into three groups. In this study, participants and researchers are not aware of which group the patient is in and which medication he is taking. As the clinical caregiver will take the medicine and the patient does not know what medicine he is taking. 3 Severe isolated brain trauma. Intervention 1: Intervention group1: Propranolol From abidi Pharmacy: The dose of 1 mg, injectable, starts in the first 24 hours after admission for patients in this group and continues until two weeks later. After transferring the patient from the intensive care unit to the ward and the ability to tolerate the drug, 40 mg of propranolol is administered as a pill every twelve hours orally. Intervention 2: Intervention group2: Enalapril From abidi Pharmacy. The dose of 2.5 mg, gavage, in the first 24 hours after admission for patients in this group (injectable form of this drug is not available in Iran)It continues until two weeks later. The goal is to maintain the patient's blood pressure between 160-100. If the pressure is not controlled, the dose can be increased to 5 mg every 12 hours. If the pressure drops below 100 mm Hg, the drug will hold. Intervention 3: Control group: This group receives only routine care after head trauma. 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 more information
public Mehdi Mahmoudkhani
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mahmoodkhani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehdi Mahmoudkhani
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mahmoodkhani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Severe trauma Age greater than or equal to 18 years No previous use of beta-blockers or Angiotensin-converting enzyme at home Informed consent of the patient's guardian or legal guardian to admit the patient to the study 18 years no limit Both Renal artery stenosis Chronic kidney disease History of drug allergy Hyperkalemia High creatinine Bradycardia or heart block S06.2X Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: Propranolol From abidi Pharmacy: The dose of 1 mg, injectable, starts in the first 24 hours after admission for patients in this group and continues until two weeks later. After transferring the patient from the intensive care unit to the ward and the ability to tolerate the drug, 40 mg of propranolol is administered as a pill every twelve hours orally. Intervention group2: Enalapril From abidi Pharmacy. The dose of 2.5 mg, gavage, in the first 24 hours after admission for patients in this group (injectable form of this drug is not available in Iran)It continues until two weeks later. The goal is to maintain the patient's blood pressure between 160-100. If the pressure is not controlled, the dose can be increased to 5 mg every 12 hours. If the pressure drops below 100 mm Hg, the drug will hold. Control group: This group receives only routine care after head trauma Glasgow Outcome Score. Timepoint: Three months after the intervention. Method of measurement: Glasgow Outcome Scale to measure level of consciousness. Esfahan University of Medical Sciences Approved 2021-04-20 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate Isfahan Isfehan Iran (Islamic Republic of)