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IRCT20190522043672N6 IRCT 2025-07-12 Mashhad University of Medical Sciences Studying the effect of pentoxifylline administration on the treatment of children with sepsis Studying the effect of pentoxifylline administration on the prognosis of children with community-acquired sepsis. 2025-07-22 anticipated 36 Complete https://irct.ir/trial/84277 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 community acquired sepsis. Intervention 1: Intervention group: Patients in this group receive a suspension prepared from a 400 mg pentoxifylline tablet (the tablet is crushed at the time of administration and suspended in water) with an oral dose of 20 mg per kilogram per day, in three divided doses. The treatment continues for one week. Intervention 2: Control group: The control group will use a tablet made from Oisel and lactulose, which is completely similar to the original drug in terms of appearance and color. This drug is prepared as a suspension in water and administered to the patient. Yes - There is a plan to make this available What will be shared: After the results are published in reputable scientific journals, interested parties can access the article. When: The period of access to results begins after the completion of the research. To whom: All people interested in the research topic can access the results. Conditions: After the results are published in the form of a thesis and article, those interested in further explanations can reach the authors through the communication channels included in the article and ask their questions, and if they need raw data, they can send their request. After the research team reviews it, approval or disapproval of sending the data will be announced. Where to obtain: To receive documentation, you can refer to the email address or phone number of the author responsible for responding. How to obtain: After receiving a request for data/documents, the requests will be reviewed within a maximum of one week and the results will be communicated to the individuals. Comments:
public Majid Sezavar
Akbar University Children's Hospital Shahid Kaveh Avenue, Near 14th Crossway
Mashhad Iran (Islamic Republic of) 9173595100 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences scientific Majid Sezavar
Akbar University Children's Hospital Shahid Kaveh Avenue, Near 14th Crossway
Mashhad Iran (Islamic Republic of) 9173595100 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) A child with sepsis is admitted to the intensive care unit of Akbar Children's Hospital in Mashhad. Meets at least two of the criteria for systemic inflammatory response syndrome Age between 1month and 10 years 1 month 10 years Both children with adrenal insufficiency lack of parental consent for the child s continued participation in the study Those who are known to be intolerant to Methylxanthines and Pentoxifylline A41 Other sepsis Treatment - Drugs Placebo Intervention group: Patients in this group receive a suspension prepared from a 400 mg pentoxifylline tablet (the tablet is crushed at the time of administration and suspended in water) with an oral dose of 20 mg per kilogram per day, in three divided doses. The treatment continues for one week. Control group: The control group will use a tablet made from Oisel and lactulose, which is completely similar to the original drug in terms of appearance and color. This drug is prepared as a suspension in water and administered to the patient. Heart rate. Timepoint: Daily examinations by an intensive care specialist continue for one week before the intervention begins. Method of measurement: Monitoring Device. Respiratory rate. Timepoint: Daily examinations by an intensive care specialist continue for one week before the intervention begins. Method of measurement: Monitoring Device. Blood oxygen saturation. Timepoint: Daily examinations by an intensive care specialist continue for one week before the intervention begins. Method of measurement: Pulse Oximetry. Blood Pressure. Timepoint: Daily examinations by an intensive care specialist continue for one week before the intervention begins. Method of measurement: Monitoring Device. Length of stay in the intensive care unit. Timepoint: Daily check-ups by the intensive care physician continue for one week before the intervention. Method of measurement: Researcher-made questionnaire. Need for a ventilator. Timepoint: Daily checks by an intensive care physician continue for one week before the intervention begins. Method of measurement: Temporarily or permanently unable to breathe independently. Need for a vasopressor. Timepoint: Daily checks by an intensive care physician continue for one week before the intervention begins. Method of measurement: Monitoring device. Mortality. Timepoint: Daily examinations by an intensive care physician continue for one week from the start of the intervention. Method of measurement: Monitoring device. Mashhad University of Medical Sciences Approved 2024-09-29 Ethics committee of Mashhad University of Medical Sciences University Street, Gharibshi Building, Vice Chancellery for Research, University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)