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IRCT20210711051839N1 IRCT 2021-11-04 Mashhad University of Medical Sciences Prevention of acute respiratory problems in trauma patients ARDS The effect of pentoxifylline on the incidence rate of acute respiratory distress syndrome (ARDS) in trauma patients 2021-10-25 anticipated 62 Complete https://irct.ir/trial/57661 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Type of clinical trial: superiority, parallel, triple blinded, block randomization, allocation concealment: Sealed envelopes Generating a random allocation sequence using "www.randomization.com" for 62 people, will be done in codes A and B, and the allocation will be hidden using a blurred and numbered sealed envelope, Blinding description: When the codes are provided and delivered to the researcher located in Kamyab Hospital, the patient is randomly placed in one of the two groups: intervention or placebo (based on the codes). The related code is recorded in the CRF form. The patient is supported by a nurse who is provided with the above form. The delivery of drugs is performed by the nurse, who is uninformed of the content of the codes and the type of pills, and the evaluator who is unaware of which drug the patient received and knows only the assigned code, performs relevant assessments. Furthermore, all patients prone to ARDS are recognized by a specified physician. After recording the history and results, the physician provides the forms to the person who analyzes the data, in the form of a code, and the data analysis is performed without the knowledge of the data analyzer of the type of drug and the content of the codes. 3 Acute Respiratory Distress Syndrome. Intervention 1: Intervention group: In the intervention group, patients received a suspension prepared from pentoxifylline tablets at a dose of 400mg/day in three divided doses for one week. Intervention 2: Control group: In the placebo group, patients receive a suspension prepared from a placebo tablet as the previous method at the time of administration and in 3 separate doses per day for one week. 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 It is not yet known if there will be a plan to make this available.
public Vahid Jomehzadeh
Mashhad University of Medical Sciences, Azadi square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3884 1635 JomehzadehV@mums.ac.ir Mashhad University of Medical Sciences scientific Vahid Jomehzadeh
Mashhad University of Medical Sciences, Azadi square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3884 1635 JomehzadehV@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Trauma patients at risk for ARDS who have lipsā‰„4 based on lung injury prediction score (lips) 20 years 40 years Both Not having written informed consent. Patients with adrenal insufficiency. Patients with inflammation of the blood vessels. Patients with intolerance to methylxanthine and pentoxifylline. Patients who can not be prescribed the drug orally. Occurrence of possible drug-related side effects if dangerous or intolerable to the patient. J80 Acute respiratory distress syndrome Treatment - Drugs Placebo Intervention group: In the intervention group, patients received a suspension prepared from pentoxifylline tablets at a dose of 400mg/day in three divided doses for one week. Control group: In the placebo group, patients receive a suspension prepared from a placebo tablet as the previous method at the time of administration and in 3 separate doses per day for one week. Incidence of acute respiratory distress syndrome. Timepoint: During the study and at the end of the study. Method of measurement: Diagnosis based on criteria for diagnosing acute respiratory distress syndrome. Respiration rate. Timepoint: At baseline and during the receive of the medication. Method of measurement: Cardiac Monitoring. Heart rate. Timepoint: At baseline and during the receive of the medication. Method of measurement: Cardiac Monitoring. Continuous pulse oximetry. Timepoint: At baseline and during the receive of the medication. Method of measurement: Capnography. Blood pressure. Timepoint: At baseline and during the receive of the medication. Method of measurement: Cardiac Monitoring. Blood gas factors. Timepoint: At baseline and during the receive of the medication. Method of measurement: Capnography. Mashhad University of Medical Sciences Approved 2021-05-25 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Azadi square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)