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IRCT20181104041551N4 IRCT 2024-02-01 Mazandaran University of Medical Sciences Evaluation of the effect of melatonin on inflammatory factors and clinical outcomes in sepsis Evaluation of the effect of melatonin on inflammatory factors and clinical outcomes in sepsis patients hospitalized in the Intensive Care Unit 2024-02-09 anticipated 56 Complete https://irct.ir/trial/73745 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked random allocation method will be used to randomly assign the patients to two intervention groups and the control group. For this purpose, the "randbetween" formula will be used in Excel software. The generated numbers will be between 1 and 6. Then, based on the generated number, samples will be assigned to the intervention and control groups, Blinding description: Melatonin and placebo medicine will be placed in separate packages. Only the main operator of the study will know how to assign the codes. The patient, the anesthesiologist (data collector) and the statistical evaluator will be blind in this study. At the end of the study, the codes will be broken for statistical analysis. 3 sepsis. Intervention 1: Intervention group: Melatonin with a dose of 15 mg per day. It should be noted that the routine treatment of patients (such as receiving antibiotics, conventional supportive treatments, etc.) will not change during the intervention period. Entering this study will not lead to a change in the patient's routine treatment process. The duration of the intervention will be 7 days. Intervention 2: Control group: They will receive a pill that is similar in appearance and color to the intervention group but contains starch or lactulose. Yes - There is a plan to make this available What will be shared: Files related to the results of laboratory tests and statistical analyses When: After completing the study and publishing the article To whom: Researchers working in academic and scientific institutions Conditions: Only statistical analyzes are allowed for use in review articles Where to obtain: Dr Fatemeh Heydari How to obtain: Sending an email to Dr Fatemeh Heydari - checking the request - if approved, sending it to the requester Comments:
public Dr. Fatemeh Heydari
Imam Hospital, Amir Mzandarani Blvd.
Sari Iran (Islamic Republic of) 5714854397 +98 11 3335 0672 f.heydari@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr Fatemeh Heydari
Sari-Amir Mazandarani Boulevard- Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 4816633131 +98 11 3335 0670 fateme58@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with early phase of sepsis Not taking antioxidant supplements Informed consent of the patient or his/her legal guardian to participate in the study 18 years no limit Both Autoimmune diseases or cancer Septic shock that requires inotrope or vasopressor drugs Hepatic failure Renal failure requiring dialysis Intestinal obstruction, ileus, gastroparesis, or other gastrointestinal conditions that can affect intestinal absorption Pregnancy and breastfeeding History of sleep disorders Attending another study at the same time A41 Other sepsis Treatment - Drugs Treatment - Other Intervention group: Melatonin with a dose of 15 mg per day. It should be noted that the routine treatment of patients (such as receiving antibiotics, conventional supportive treatments, etc.) will not change during the intervention period. Entering this study will not lead to a change in the patient's routine treatment process. The duration of the intervention will be 7 days. Control group: They will receive a pill that is similar in appearance and color to the intervention group but contains starch or lactulose. The interleukin-6 level. Timepoint: At baseline and 7 days after (the end of study). Method of measurement: Elysia kit. The interleukin-10 level. Timepoint: At baseline and 7 days after (the end of study). Method of measurement: Elysia kit. WBC (diff), CRP and PCT. Timepoint: At baseline and 7 days after (the end of study). Method of measurement: Laboratory report. Total antioxidant capacity. Timepoint: At baseline and 7 days after (the end of study). Method of measurement: Elysia kit. SOFA score. Timepoint: At baseline and 7 days after (the end of study). Method of measurement: Laboratory and clinical findings. Comparison of the effect of melatonin with placebo on the GCS in sepsis patients. Timepoint: Daily. Method of measurement: Clinical observation. Comparison of the effect of melatonin with placebo on the need for ventilation and duration of ventilation in sepsis patients. Timepoint: Dialy. Method of measurement: Clinical observation. Comparison of the effect of melatonin with placebo on the mortality rate of sepsis patients. Timepoint: Daily. Method of measurement: Clinical observation. Mazandaran University of Medical Sciences Approved 2023-08-14 Research Ethics Committee, Imam Hospital of Sari, Mazandaran University of Medical Sciences Imam Hospital, Amir Mzandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)