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IRCT20210524051384N10 IRCT 2023-06-20 Rasht University of Medical Sciences Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn: A clinical trial 2023-06-22 anticipated 78 Complete https://irct.ir/trial/70203 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, in order to assign patients to the intervention and control groups, the limited randomization approach will be used in the block randomization method. In order to prevent revealing the last allocation in the blocks, we will consider the size of the blocks randomly with sizes 4 and 6. The sequences inside each block are randomly determined so that half of the members of each block are assigned to the control group and the other half to the intervention group. For this purpose, the "Sealed envelope” online software is used to determine the blocks, so that the random blocks and sequences of each one are specified, and then the patients are assigned to the intervention and control groups based on the specified sequence, Blinding description: Blinding in this study will be done in such a way that the patients were assigned to the intervention and control groups by the statistician, and the student colleagues will be responsible for conducting the interventions. Evaluation and completion of the checklists on specific determined times was the responsibility of the surgeon and project manager, who was not aware of the grouping of the patients. N/A Burn. Intervention 1: Intervention group: The treatment with oral ranolazine 500 mg tablets for patients in the intervention group will be started in the emergency room in such a way that the maximum time interval between the occurrence of the accident and the start of treatment is 6 hours. It should be noted that patients in the intervention group will take the prescribed pill with water. The medicine will continue to be taken every 12 hours until the fifth day after the injury. It should be mentioned that the patients received standard burn treatment during the entire hospitalization. These measures include: Resuscitation with fluids based on the Parkland formula and modification based on urinary output, monitoring vital signs and laboratory findings, regular washing and wound debridement and dressing using local antibiotics and surgical debridement and grafting based on the patient's need. Additionally, if any complication caused by the drug was observed in the study group, the patient was immediately excluded from the study and all necessary measures were taken to eliminate the complication and recover the patient as quickly as possible. Intervention 2: Control group: Patients in the control group receive standard burn treatments since the admission to emergency room. These measures include: Resuscitation with fluids based on the Parkland formula and modification based on urinary output, monitoring vital signs and laboratory findings, regular washing and wound debridement and dressing using local antibiotics and surgical debridement and grafting based on the patient's need. During the hospitalization, the required information will be collected from the patients. This information includes demographic data, vital signs, renal factors, local symptoms such as infection and itching, graft size, clinical outcome and length of hospitalization. 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 Still undecided - no release schedule yet
public Dr. Mohammad Reza Mobayen
Namjou st.
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific Dr. Mohammad Reza Mobayen
Namjou st.
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Age range from 18 to 65 years Acute burn in less than 6 hours Total body surface area (TBSA) between 20 - 50% patients of American Society of Anesthesiologists (ASA) class I (a normal healthy person) Fill out the informed consent 18 years 65 years Both Having severe hypertension blood pressure (BP) ≥ 160/90 mmHg or systolic pressure below 100 mmHg Ischemic changes in electrocardiogram (ECG) Heart rate less than 70 beats per minute Pregnant women Peripheral vascular disease Presence of inhalation injury Presence of burn shock (including decreased cardiac output, increased vascular resistance, hypovolemia and hypoperfusion following severe burns) Electrical and chemical burns Kidney or liver failure caused by burns (according to the kidney and liver metabolism of the drug) Presence of drug interactions with the patient's previous medications T20 Burn and corrosion of head, face, and neck Treatment - Drugs Treatment - Other Intervention group: The treatment with oral ranolazine 500 mg tablets for patients in the intervention group will be started in the emergency room in such a way that the maximum time interval between the occurrence of the accident and the start of treatment is 6 hours. It should be noted that patients in the intervention group will take the prescribed pill with water. The medicine will continue to be taken every 12 hours until the fifth day after the injury. It should be mentioned that the patients received standard burn treatment during the entire hospitalization. These measures include: Resuscitation with fluids based on the Parkland formula and modification based on urinary output, monitoring vital signs and laboratory findings, regular washing and wound debridement and dressing using local antibiotics and surgical debridement and grafting based on the patient's need. Additionally, if any complication caused by the drug was observed in the study group, the patient was immediately excluded from the study and all necessary measures were taken to eliminate the complication and recover the patient as quickly as possible. Control group: Patients in the control group receive standard burn treatments since the admission to emergency room. These measures include: Resuscitation with fluids based on the Parkland formula and modification based on urinary output, monitoring vital signs and laboratory findings, regular washing and wound debridement and dressing using local antibiotics and surgical debridement and grafting based on the patient's need. During the hospitalization, the required information will be collected from the patients. This information includes demographic data, vital signs, renal factors, local symptoms such as infection and itching, graft size, clinical outcome and length of hospitalization. Graft to TBSA (total body surface area) percent ratio. Timepoint: At discharge. Method of measurement: Measurements based on Wallace criteria. Mortality. Timepoint: At discharge. Method of measurement: Based on the clinical outcome recorded in the patients' files. Length of hospital stay. Timepoint: At discharge. Method of measurement: Based on patient's file. SIRS (Systemic inflammatory response syndrome). Timepoint: On the 1st, 3rd and 7th days of hospitalization. Method of measurement: Based on criteria including temperature, heart rate, respiratory rate, and WBC (white blood cell) count. Infection. Timepoint: On the 1st, 3rd and 7th days of hospitalization. Method of measurement: Based on clinical decision of doctor. Rasht University of Medical Sciences Approved 2023-05-17 Ethics committee of Guilan University of Medical Sciences Guilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)