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IRCT20230127057247N1 IRCT 2023-08-12 Tehran University of Medical Sciences Effects of combined dietary supplementation of protein and creatine on outcomes in patients with peritrochanter fracture ERAS Effects of combined dietary supplementation of protein and creatine on outcomes and acceleration of postoperative recovery in patients with peritrochantic fracture: A double-blind interventional esoteric study 2023-08-01 anticipated 90 Complete https://irct.ir/trial/68400 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random numbers table, Blinding description: The supplement and placebo are blinded by the manufacturer in English letters and the patient, the executor, the researcher and the manufacturer are unaware of the complete collection of the fear and its data from receiving the supplement or placebo by the patient. N/A Femoral neck fracture, intertroch fracture and subtroch of femoral fracture. Intervention 1: Intervention group: including patients with pretrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referred to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases according to the randomization table, they were divided into 2 groups. In the intervention group, after collecting demographic information and The request for tests includes cbc-crp-albumin-pre-albumin. Depending on the location and type of fracture and the clinical conditions, the patient is subjected to internal surgical fixation, and then after discharge for one month, a daily dose of 30 mg protein sachets dissolved in water, which includes He consumed creatinine, essential amino acids and protein, and after a month, the patient will be asked for the aforementioned tests and will be analyzed. Intervention 2: Control group: including patients with peritrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referring to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases, according to the randomization table, they were divided into 2 groups, in the control group, after collecting demographic information and Request for tests including cbc-crp-albumin-pre-albumin surgery depending on the location and type of fracture and the clinical conditions of the patient is subjected to internal surgical fixation and then after discharge for a month daily placebo protein sachets of 30 mg soluble in water which includes dextrose and after a month, the patient will be asked for the above-mentioned tests and will be analyzed. The table of the amount of starting the park before and after the surgery was completed for him in a comparative manner. 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 No more information
public Mohammad Reza Donyazad
the end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex (RA) - Orthopedic Department
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6697 0295 dr.mrdonyazad@yahoo.com Tehran University of Medical Sciences scientific Mohammad Reza Donyazad
the end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex (RA) - Orthopedic Department
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6697 0295 dr.mrdonyazad@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with Femur neck fracture or intertroch fracture or subtrochantric fracture 18 years no limit Both Under 18 y/o Pregnancy Renal failure S72.14 Intertrochanteric fracture of femur Treatment - Drugs Treatment - Drugs Intervention group: including patients with pretrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referred to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases according to the randomization table, they were divided into 2 groups. In the intervention group, after collecting demographic information and The request for tests includes cbc-crp-albumin-pre-albumin. Depending on the location and type of fracture and the clinical conditions, the patient is subjected to internal surgical fixation, and then after discharge for one month, a daily dose of 30 mg protein sachets dissolved in water, which includes He consumed creatinine, essential amino acids and protein, and after a month, the patient will be asked for the aforementioned tests and will be analyzed. Control group: including patients with peritrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referring to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases, according to the randomization table, they were divided into 2 groups, in the control group, after collecting demographic information and Request for tests including cbc-crp-albumin-pre-albumin surgery depending on the location and type of fracture and the clinical conditions of the patient is subjected to internal surgical fixation and then after discharge for a month daily placebo protein sachets of 30 mg soluble in water which includes dextrose and after a month, the patient will be asked for the above-mentioned tests and will be analyzed. The table of the amount of starting the park before and after the surgery was completed for him in a comparative manner. Nutritional level by checking blood lymphocyte level changes. Timepoint: At the time of hospitalization and a month later. Method of measurement: Request for testing at the time of hospitalization and one month later. Nutritional level by checking changes in blood albumin level. Timepoint: At the time of hospitalization and a month later. Method of measurement: Request for testing at the time of hospitalization and one month later. Nutritional level by checking changes in blood CRP level. Timepoint: At the time of hospitalization and a month later. Method of measurement: Request for testing at the time of hospitalization and one month later. Changes in quality of life and the ability to perform daily activities and walk. Timepoint: At the time of hospitalization and a month later. Method of measurement: Parker questionnaire. 30-day mortality. Timepoint: 30 days after surgery. Method of measurement: questionnaire. Time interval between hospitalization and surgery. Timepoint: Hospitalization day and surgery day. Method of measurement: questionnaire. Complications occurred for the patient including delirium and clinical venous thrombosis. Timepoint: In 30 days after surgery. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2022-09-23 Tehran university of medical Science research committe ethics 6th Floor, Central Building, Tehran University of Medical Sciences, Qods Street Intersection, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)