Studying the effect of pentoxifylline administration on the prognosis of children with community-acquired sepsis.

Studying the effect of pentoxifylline administration in patients with sepsis

The clinical trial has a control group, with parallel groups, a triple-blind design, and randomization using a random number table. The patients' mortality risk assessment scores are evaluated before the intervention. Ultimately, 36 patients will be randomly assigned to two intervention and control groups.

This study will be conducted on 36 children hospitalized in the pediatric intensive care unit of Akbar Children's Hospital. After obtaining parental consent, random codes will be assigned to the patients, the codes will be recorded in the case report form, and the patients will be randomly assigned to one of the intervention or control groups. The nurse, physician, and data analyst are all unaware of the content of the codes.

Patient entry requirements: 1. Age range from one month to ten years 2. Children with sepsis admitted to the Akbar Intensive Care Unit with positive systemic inflammatory response syndrome in the context of a proven or probable infection Non-entry requirements: 1. History of hospitalization in the past three months or living in care facilities 2. Immunodeficiency

The intervention group will receive 20 mg/kg/day Pentoxifylline, and the control group will receive an equivalent volume of water for seven days.

In all children studied, heart rate, respiratory rate, continuous pulse oximetry, and blood pressure are measured, and blood gases, inflammatory factors, length of stay in the intensive care unit, need for ventilators and vasopressors, and mortality are assessed.

To randomize and divide patients into two groups (control and intervention), and to determine the type (interventional drug or placebo), a random number table method will be used. The table assigning each code to each patient will be provided to the researcher located in the Akbar Hospital pharmacy. It should be noted that this researcher is fully aware of the types of codes and knows which drug each patient has received. The drugs are also provided to him based on the number (A or B), and he is fully aware of which drug or placebo. This researcher is not involved in prescribing, evaluating treatment, or analyzing data and is only responsible for maintaining the codes and assigning patients to one of the relevant codes.

After the codes are prepared and provided to the researcher located in the Akbar Hospital pharmacy, the patient is randomly assigned to one of the groups based on the codes. The relevant code is recorded in the Case report form. The patient is introduced to a nurse who is provided with the above form. The delivery of the drugs is done by a nurse (therapist) who is unaware of the content of the codes and the type of pills. In the meantime, the evaluator (physician), who is different from the therapist (nurse) and does not know which drug the patient received and is only aware of the assigned code, performs the relevant assessments. To increase the accuracy of the study, all patients with sepsis are identified by a physician. After recording the history and results, this physician provides the forms to the person who analyzes the data in code form, and the data analysis is also performed without the knowledge of the person analyzing the data about the type of drug and the content of the codes.

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