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IRCT20210919052515N5 IRCT 2022-05-04 Oroumia University of Medical Sciences Assessment of the β-alanine effect in acute lower and upper extremity ischemia Assessment of the β-alanine effect on postoperative clinical outcomes in patients with acute lower and upper extremity ischemia 2022-05-22 anticipated 40 Complete https://irct.ir/trial/62644 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and placebo groups using stratified block randomization based on generated numbers by random allocation software. Firstly, patients will be stratified according to the duration of thrombectomy or embolectomy into 1-2, 4-2, and 6-4 and more than 6 hours groups, and then block randomization will be performed in each stratum. So that, in this software, the number of groups (two groups including intervention or placebo) and the sample size in each stratum (for example in 1-2 stratum of the duration of thrombectomy or embolectomy) will be entered, and then in the block section, the block randomization method will be implemented. In each stratum, patients will be allocated to intervention or placebo groups based on generated numbers. Random Allocation Software version 1.0.0 has been developed by Mr.Saghaei, MD. department of anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blinded to the intervention or placebo groups. Beta-alanine and placebo will be given to the patient by another surgeon (other than the researcher ) and the placebo tablets will be similar to the Beta-alanine tablets in shape and size. Group names will be encoded with the letters A and B. 3 acute extremity ischemia. Intervention 1: Intervention group: Patients in the intervention group will be received 4 gr of oral β-alanine before surgery and 4 hours after surgery. The routine treatment of patients is receiving an anticoagulant (heparin or enoxaparin) before or after surgery. Intervention 2: Control group: Patients in the placebo group will receive 4 gr of placebo before surgery and 4 hours after surgery in addition to routine treatment. The routine treatment of patients is receiving an anticoagulant (heparin or enoxaparin) before or after surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Naser Masoudi
Imam Khomeini hospital., Ershad Ave., Modarres Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 masoudi.n@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Naser Masoudi
Imam Khomeini hospital., Ershad Ave., Modarres Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 masoudi.n@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Acute extremity ischemia patients Having surgical indications and the possibility of limb preservation no limit no limit Both Gangrene of the limbs Motlelling of the limbs Amputation Indication Renal failure diseases BD30.2 Acute lower limb arterial occlusion Treatment - Other Treatment - Other Intervention group: Patients in the intervention group will be received 4 gr of oral β-alanine before surgery and 4 hours after surgery. The routine treatment of patients is receiving an anticoagulant (heparin or enoxaparin) before or after surgery. Control group: Patients in the placebo group will receive 4 gr of placebo before surgery and 4 hours after surgery in addition to routine treatment. The routine treatment of patients is receiving an anticoagulant (heparin or enoxaparin) before or after surgery. Loss of limbs. Timepoint: After the intervention at hospitalization. Method of measurement: Clinical examination. Complications. Timepoint: After the intervention at hospitalization. Method of measurement: Clinical examination. Mortality. Timepoint: After the intervention at hospitalization. Method of measurement: Yes/no. Oroumia University of Medical Sciences Approved 2022-01-23 Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences Imam Khomeini hospital., Ershad Ave., Modarres Blvd., Urmia., Iran. Urmia West Azarbaijan Iran (Islamic Republic of)