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IRCT20221121056570N2 IRCT 2023-08-15 Ahvaz University of Medical Sciences Vitamin D in Trauma The Effect of single dose Vitamin D injection on renal function in Patients with Traumatic Injuries Hospitalized in Intensive Care Unit 2023-08-23 anticipated 60 Complete https://irct.ir/trial/68069 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done by the method of individual assigning of random numbers with blocks of 4. The tool used to generate random numbers with blocks of 4 is the online software of the Sealedenvelope.com website. Every new patient who is admitted to the intensive care unit, if he meets the inclusion criteria for entering the study, will be placed in one of the A or B groups in the order of arrival and based on the order of randomly generated numbers. For allocation concealment, except for the hospital pharmacist who prepares the drugs for injection and is not present in the study, no one else knows which of the placebo or vitamin D groups referred to each of the A and B groups, Blinding description: Patients (or the patient's family), nurses (care providers), research assistants (who are in charge of data collection) and the statistical analyst will not know about the drug groups (intervention or control) and delivery of medication will be done by a person selected from outside the department (hospital pharmacist). 3 Acute kidney failure. Intervention 1: This group will receive an intramuscular dose of placebo (1 mililiter of isotonic NACL 0.9% manufactured by Shahid Ghazi Pharmaceutical company, Tabriz, Iran) during the first 24 hours of hospitalization. Intervention 2: Intervention group: This group will receive an intramuscular dose of medicine (300,000 units of vitamin D manufactured by Iran's Darupakhsh Pharmaceutical Company) during the first 24 hours of hospitalization. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: All data will be available from the publication of the research paper To whom: The data will only be available to researchers working in academic and scientific institutions Conditions: Researchers can request to receive data for research and clinical uses and to conduct systematic reviews and meta-analyses Where to obtain: It is possible to receive data by sending an email (drsavaie@gmail.com) How to obtain: The data will be sent by email no later than one month after the request by academic researchers and scientific centers Comments: If requested by the journal publishing the article, the data can be uploaded on the journal's website
public Mosen savaie
Golestan
Ahwaz Iran (Islamic Republic of) 6136854578 +98 61 3320 4558 drsavaie@gmail.com Ahvaz University of Medical Sciences scientific Mohsen savaie
Golestan hospital
Ahwaz Iran (Islamic Republic of) 6136854578 +98 61 3320 4558 drsavaie@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Traumatic patient Age more than 18 Hospitalized in intensive care unit more than 24 hours Revised trauma score (RTS) >=6 New trauma score (NTS) >=8 18 years no limit Both Chronic renal failure Cancer Autoimione disease Abstinece of patient N17 Acute kidney failure Placebo Treatment - Drugs This group will receive an intramuscular dose of placebo (1 mililiter of isotonic NACL 0.9% manufactured by Shahid Ghazi Pharmaceutical company, Tabriz, Iran) during the first 24 hours of hospitalization. Intervention group: This group will receive an intramuscular dose of medicine (300,000 units of vitamin D manufactured by Iran's Darupakhsh Pharmaceutical Company) during the first 24 hours of hospitalization. Creatinin. Timepoint: Before intervention and daily till discharge from ICU (maximum 28 days). Method of measurement: biochemical auto-analyser. Blood urea nitrogen. Timepoint: Before intervention and daily till 28 days or discharge time. Method of measurement: Biochemical auto-analyser. Body mass index. Timepoint: Before intervention and 28th day or at discharge time. Method of measurement: Based on the result of dividing weight in kilograms by height in meters. Abdominal circumference. Timepoint: Before intervention and 28th day or at discharge time. Method of measurement: Mesurment with a meter. Mortality. Timepoint: After 28 days or at discharge time. Method of measurement: Alive or dead. Ventilator free days (in first 28 days). Timepoint: After 28 days or at discharge time. Method of measurement: The number of days of the first 28 days that the patient was not connected to the ventilator. Ahvaz University of Medical Sciences Approved 2023-01-17 Ethics committee of AJUMS Golestan Ahwaz Khouzestan Iran (Islamic Republic of)