The effect of pentoxifylline on the incidence rate of acute respiratory distress syndrome (ARDS) in trauma patients

Evaluating the effect of pentoxifylline administration on the incidence rate of acute respiratory distress syndrome (ARDS) in trauma patients

Randomized triple-blind clinical trial on 62 patients.

The effect of pentoxifylline on the incidence of ARDS in trauma patients will be examined in Kamyab Hospital, Mashhad. Sixty-two patients were identified by an intensive care specialist who has completed the entry and exit requirements, the informed consent form is signed by the guardian and entered into the study. Patients are divided into two groups of control and intervention, based on the type of drug received. Using the allocated codes, the intervention group receives a solution of pentoxifylline for one week and the placebo group receives a placebo for one week. Blinding individuals would be patient, doctor, nurse, and analyzer.

Age between 18 and 65 years Trauma patients at risk for ARDS who have lips≥4 based on lung injury prediction score (lips) will be included in the study. Patients with no written informed consent, patients with adrenal insufficiency, patients with inflammation of the blood vessels, patients with intolerance to methylxanthine and pentoxifylline, patients who cannot be prescribed the drug orally, and occurrence of possible drug-related side effects if dangerous or intolerable to the patient are not included in the study.

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. 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.

The incidence rate of acute respiratory distress syndrome in trauma patients

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.

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.