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IRCT20210524051384N5 IRCT 2021-11-09 Rasht University of Medical Sciences Effect of Remote Ischemic Preconditioning in treatment of burns Effect of Remote Ischemic Preconditioning on complications and clinical outcome in patients with severe burn, A randomized clinical trial 2021-12-06 anticipated 32 Complete https://irct.ir/trial/59683 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups. For this purpose, four blocks with a ratio of 1: 1 will be considered. Sequences are marked in sealed envelopes with the letters A (intervention group) and B (control group). We will consider the size of the blocks randomly with a size of 4 or 6 to prevent the latest allocation from being detected. In the randomization process, random allocation sequences are identified by a statistician, and two student collaborators in the project will register participants and allocate them to interventions, Blinding description: In order to blind the subjects (patients) in the control group, a RIPC-like protocol with lower pressure will be performed in which the applied pressure is incapable of causing ischemia. In order to blind the researcher (physician who monitors the treatment process of patients in terms of studied variables such as wound examination, systemic complications, length of hospital stay, and others), allocators determine the groups without prior information using the allocation concealment method. The project will be performed based on patients groups by nurses or trained individuals. Final evaluation will be done by evaluators and physicians. In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups. N/A Burn. Intervention 1: Intervention group (Patients receiving RIPC procedure): RIPC procedure will be performed on the first day of hospitalization under the following protocol twice with an interval of 12 hours: 20 minutes after using NSAID as analgesic to prevent pain, sphygmomanometer will be attached to the patient's healthy arm and will be remained under the pressure of 200 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. All patients (both intervention group and control group) will receive the routine treatment in burn management. For all patients, ٪TBSA and Used graft will be calculated using the Wallace scale on admission. Also, demographic characteristics, including age, sex, cause and degree of burn will be recorded. The length of hospital stay is defined as the length of time from the day of admission to the day of discharge. Laboratory parameters including ESR and CRP, renal profile (BUN, creatinine) and liver enzymes (AST, ALT and ALP) will be measured through venous blood samples according to the laboratory protocol of Velayat Medical Center Rasht on days 1,3,7,14 and 28. Additionally, local complications including burning, itching and infection of the wound will be checked during the examination. Intervention 2: Control group (Patients receiving RIPC-LIKE procedure): RIPC procedure will be performed on the first day of hospitalization under the following protocol twice with an interval of 12 hours: 20 minutes after using NSAID as analgesic to prevent pain, sphygmomanometer will be attached to the patient's healthy arm and will be remained under the pressure of 60 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. All patients (both intervention group and control group) will receive the routine treatment in burn management. For all patients, ٪TBSA and Used graft will be calculated using the Wallace scale on admission. Also, demographic characteristics, including age, sex, cause and degree of burn will be recorded. The length of hospital stay is defined as the length of time from the day of admission to the day of discharge. Laboratory parameters including ESR and CRP, renal profile (BUN, creatinine) and liver enzymes (AST, ALT and ALP) will be measured through venous blood samples according to the laboratory protocol of Velayat Medical Center Rasht on days 1,3,7,14 and 28. Additionally, local complications including burning, itching and infection of the wound will be checked during the examination. 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 I haven't decided yet - the release schedule is still unknown
public Mohammad Reza Mobayen
Namjoo street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific Dr. Mohammad Reza Mobayen
Namjoo street
‌Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 65 years Acute burn injury within 24 hours 20 to 50 percent TBSA (total body surface area) Patient classified as class 1 ASA (American Society of Anesthesiologists) : Normal healthy person Signed informed consent 18 years 65 years Both Severe hypertension = BP (Blood pressure) ≥160/90 mmHg Ischemic changes in ECG (Electrocardiogram) Pregnant women Peripheral vascular diseases Inhalation injury Burn shock: decreased CO (Cardiac output), increased systemic vascular resistance, hypovolemia and hypoperfusion induced by severe burn injury Patients with burn injury in both upper limbs in which the procedure couldn't be performed T20 Burn and corrosion of head, face, and neck Treatment - Other Treatment - Other Intervention group (Patients receiving RIPC procedure): RIPC procedure will be performed on the first day of hospitalization under the following protocol twice with an interval of 12 hours: 20 minutes after using NSAID as analgesic to prevent pain, sphygmomanometer will be attached to the patient's healthy arm and will be remained under the pressure of 200 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. All patients (both intervention group and control group) will receive the routine treatment in burn management. For all patients, ٪TBSA and Used graft will be calculated using the Wallace scale on admission. Also, demographic characteristics, including age, sex, cause and degree of burn will be recorded. The length of hospital stay is defined as the length of time from the day of admission to the day of discharge. Laboratory parameters including ESR and CRP, renal profile (BUN, creatinine) and liver enzymes (AST, ALT and ALP) will be measured through venous blood samples according to the laboratory protocol of Velayat Medical Center Rasht on days 1,3,7,14 and 28. Additionally, local complications including burning, itching and infection of the wound will be checked during the examination. Control group (Patients receiving RIPC-LIKE procedure): RIPC procedure will be performed on the first day of hospitalization under the following protocol twice with an interval of 12 hours: 20 minutes after using NSAID as analgesic to prevent pain, sphygmomanometer will be attached to the patient's healthy arm and will be remained under the pressure of 60 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. All patients (both intervention group and control group) will receive the routine treatment in burn management. For all patients, ٪TBSA and Used graft will be calculated using the Wallace scale on admission. Also, demographic characteristics, including age, sex, cause and degree of burn will be recorded. The length of hospital stay is defined as the length of time from the day of admission to the day of discharge. Laboratory parameters including ESR and CRP, renal profile (BUN, creatinine) and liver enzymes (AST, ALT and ALP) will be measured through venous blood samples according to the laboratory protocol of Velayat Medical Center Rasht on days 1,3,7,14 and 28. Additionally, local complications including burning, itching and infection of the wound will be checked during the examination. Graft to TBSA (total body surface area) percent ratio. Timepoint: At the admission. Method of measurement: Measurements based on Wallace criteria. Total fluid requirement. Timepoint: At discharge. Method of measurement: Based on patients' files. Hospital stay. Timepoint: At discharge. Method of measurement: Based on patients' files. Final clinical outcome. Timepoint: At discharge. Method of measurement: Based on patients' files. Infection. Timepoint: Day 1, 3, 7, 14 and 28 post admission. Method of measurement: Based on examination done by evaluators. Itching. Timepoint: Day 1, 3, 7, 14 and 28 post admission. Method of measurement: Asking patients. Burning. Timepoint: Day 1, 3, 7, 14 and 28 post admission. Method of measurement: Asking patients. Shock index. Timepoint: Hour 1, 6, 12, 24 post admission. Method of measurement: Heartbeat per minute / systolic Blood pressure in mmHg. SIRS (Systemic inflammatory response syndrome). Timepoint: Day 1, 3, 7, 14 and 28 ‌post admission. Method of measurement: Based on body temperature, heart rate, respiratory rate, and WBC (white blood cells) count. Cr (creatinine). Timepoint: Day 1, 3, 7, 14 and 28 ‌post admission. Method of measurement: Based on patients' laboratory results. Rasht University of Medical Sciences Approved 2021-10-13 Research Ethic Committees of Guilan University of Medical science Guilan University of Medical science Rasht Guilan Iran (Islamic Republic of)