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IRCT20230301057584N1 IRCT 2023-06-04 Bandare-abbas University of Medical Sciences Investigating the effectiveness of beta-blocker on hypermetabolic response in adult patients due to acute burns Investigating the effectiveness of beta-blockers on hypermetabolic response in adult patients referred to hospital due to acute burns: a single-blind randomized clinical trial 2023-04-21 anticipated 90 Complete https://irct.ir/trial/69307 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be divided into two groups and the Random Allocation software will be used for simple randomization. concealment will be done using non-transparent envelopes, Blinding description: In this study, blinding will be done for participants. In this way, the medicine and placebo will be placed in the same packages by a person outside the study, which will be labeled with A and B codes. To blind the participants and reduce their bias, it was explained to them only at the beginning of the study that they will receive one of two types of intervention and they will not be told the exact type of treatment. 3 Condition 1: Acute Burn. Condition 2: Acute Burn. Condition 3: Acute Burn. Condition 4: Acute Burn. Condition 5: Acute Burn. Condition 6: Acute Burn. Intervention 1: Control group: In the first 24 hours of admission, patients receive normal saline solution (Ringer's lactate) and the patient's dose is calculated with the help of the Parkland formula. For patients under the standard treatment of the Ministry of Health and from the third day after the burn, they receive starch tablets (placebo) with a dose of 20 mg (every twelve hours), which is similar in appearance to propranolol tablets (the same as intervention group). Placebos will be purchased from Merck Pharmaceutical Company. Hemodynamic parameters (heart rate, blood pressure) are checked every 3 hours. The period of consumption continues until the patient's hospitalization and complete recovery and discharge from the hospital. Intervention 2: Intervention group: Patients receive normal saline solution (ringer lactate) in the first 24 hours of admission, and the patient's dose is calculated with the help of Parkland's formula. For patients, the standard treatment of the Ministry of Health begins and from the third day after the burn, patients receive oral propranolol at a dose of 20 mg (every twelve hours). This drug is prepared from Hakim Pharmaceutical Company. Hemodynamic parameters (heart rate, blood pressure) are checked every 3 hours. If a 20% reduction is maintained with a dose lower than this amount, the patient's dose will be reduced to that amount. If bradycardia occurs, propranolol is stopped and half of the mentioned dose is prescribed 16 hours later. Within 48 hours, the patient's dose will return to a fixed amount. If the patient's blood pressure falls below 65 milliliters of mercury (mmHg), the patient's dose is reduced or stopped until the patient's blood pressure returns to normal. If the parameters do not change, the next received dose will be 40 mg, and after reaching the goal, the dose will be changed to 20 mg. The period of propranolol consumption continues until the patient is hospitalized and fully recovered and discharged from the hospital. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr Sadegh Ahmadi Rashti
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 937 971 1740 66sadegh66@gmail.com Bandare-abbas University of Medical Sciences scientific Dr Sadegh Ahmadi Rashti
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 937 971 1740 66sadegh66@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Having wounds from 20 to 50% of the total body surface Consent to participate in data collection From the age of 18 to the age of 65 and of both sexes A history of acute burns in the last two days 18 years 65 years Both Medical conditions against propranolol use Head injury History of cardiopulmonary endocrine and peripheral diseases Systolic blood pressure less than 90 Heart rate less than 60 Inhalation damage History of malignancy History of AIDS Complexes related to AIDS and HIV History of IMI (less than the last 6 weeks), tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases Long-term use of corticosteroids or non-steroidal anti-inflammatory drugs Renal failure defined as creatinine greater than 3 Liver disease defined as bilirubin more than 3 Anoxic brain damage Patients with asthma and a history of airway narrowing Respiratory burn History of joint or bone disease Peripheral or central nerve damage Diabetes or taking any medication that affects the autonomic system Any type of plastering Skin wound or skin graft Contraindication to the use of propranolol Hypersensitivity to propranolol A history of hyperthyroidism, unless you are using Synthroid or other thyroid hormones Chronic opioid overdose pre-burn Receiving propranolol in the past 6 months Multiple severe allergic reactions Daily use of methylphenidate or similar stimulants Presence of hypoxic brain injury that is not expected to lead to full recovery History of chronic obstructive pulmonary disease and history of medication use including blocking agents (alpha and beta) or other antiarrhythmic drugs and medical conditions requiring glucocorticoid therapy prior to burn injury. T20.00 T21.00 T22.00 T23.00 T24.00 T25.0 Burn of unspecified degree of head, face, and neck, unspecified site Burn of unspecified degree of trunk, unspecified site Burn of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site Burn of unspecified degree of hand, unspecified site Burn of unspecified degree of unspecified site of lower limb, except ankle and foot Burn of unspecified degree of ankle and foot Placebo Treatment - Drugs Control group: In the first 24 hours of admission, patients receive normal saline solution (Ringer's lactate) and the patient's dose is calculated with the help of the Parkland formula. For patients under the standard treatment of the Ministry of Health and from the third day after the burn, they receive starch tablets (placebo) with a dose of 20 mg (every twelve hours), which is similar in appearance to propranolol tablets (the same as intervention group). Placebos will be purchased from Merck Pharmaceutical Company. Hemodynamic parameters (heart rate, blood pressure) are checked every 3 hours. The period of consumption continues until the patient's hospitalization and complete recovery and discharge from the hospital. Intervention group: Patients receive normal saline solution (ringer lactate) in the first 24 hours of admission, and the patient's dose is calculated with the help of Parkland's formula. For patients, the standard treatment of the Ministry of Health begins and from the third day after the burn, patients receive oral propranolol at a dose of 20 mg (every twelve hours). This drug is prepared from Hakim Pharmaceutical Company. Hemodynamic parameters (heart rate, blood pressure) are checked every 3 hours. If a 20% reduction is maintained with a dose lower than this amount, the patient's dose will be reduced to that amount. If bradycardia occurs, propranolol is stopped and half of the mentioned dose is prescribed 16 hours later. Within 48 hours, the patient's dose will return to a fixed amount. If the patient's blood pressure falls below 65 milliliters of mercury (mmHg), the patient's dose is reduced or stopped until the patient's blood pressure returns to normal. If the parameters do not change, the next received dose will be 40 mg, and after reaching the goal, the dose will be changed to 20 mg. The period of propranolol consumption continues until the patient is hospitalized and fully recovered and discharged from the hospital. Blood pressure. Timepoint: At the beginning of the intervention and during the intervention every 3 hours until the end of discharge from the hospital. Method of measurement: Barometer. Heart rate. Timepoint: At the beginning of the intervention and during the intervention every 3 hours until the end of discharge from the hospital. Method of measurement: patient vital signs monitoring system. Body temperature. Timepoint: At the beginning of the intervention and during the intervention every 3 hours until the end of discharge from the hospital. Method of measurement: Thermometer. Blood oxygen. Timepoint: At the beginning of the intervention and during the intervention every 3 hours until the end of discharge from the hospital. Method of measurement: Pulse Oximeter. Hospitalization in ICU. Timepoint: Before starting the intervention and After completing the intervention. Method of measurement: Count by number of days. The duration of the patient's recovery during the intervention period. Timepoint: Before starting the intervention and After completing the intervention. Method of measurement: check list. Mortality. Timepoint: Before starting the intervention and After completing the intervention. Method of measurement: Check list. TNF-alpha. Timepoint: Before starting the intervention and After completing the intervention. Method of measurement: Examination of cytokine TNF-alpha using ELISA kit. Bandare-abbas University of Medical Sciences Approved 2023-02-14 Ethics committee of Hormozgan University of Medical Sciences Research and Technology Vice-Chancellor Building, Hormozgan University of Medical Sciences Campus, Imam Hossein Blvd, Bandar Abbas, Iran Bandar Abbas Hormozgan Iran (Islamic Republic of)