Study of the melatonin effect compared to placebo on disease improvement in adult patients with sepsis and septic shock: A Randomized Controlled Trial

Introducing melatonin as an effective and safe supplement for the improvement of patients with sepsis or septic shock

A randomized clinical trial with control group, With parallel groups, double-blind, It has been randomized that the website www.sealedenvelope.com will be used for randomization on 74 patients.

The setting of the study will be the intensive care unit of Namazi Hospital in Shiraz. The study population will be all patients with sepsis or septic shock who meet the inclusion criteria. This study will be double blind in which all participants, their companions, investigators, and healthcare staff responsible for patient care will remain unaware of the group allocations until the study is completed.

Inclusion criteria: Age 18 and older; Diagnosed with sepsis or septic shock within 24 hours or more of ICU admission; Informed consent signed by patient or legal guardian; being able to swallow or have an NG tube. Exclusion criteria: Patients with a history of allergy and sensitivity to melatonin or any of its components; Pregnant and lactating patients; patients with End-stage renal disease requiring hemodialysis

Intervention group: Routine treatment plus 20 mg of melatonin orally for 5 days from the time of diagnosis of sepsis or septic shock. Control group: Routine treatment plus oral placebo, which is completely similar in shape and color to the original drug, is given for 5 days from the time of diagnosis of sepsis or septic shock.

Mortality; length of stay in the intensive care unit and hospital; duration of mechanical ventilation and vasopressor use; measurement of SOFA and APACHE II scores; need for hemodialysis; incidence of acute kidney injury

In this study, the randomized block design with double randomization method is used for random allocation. In this method, different permutations of the two treatment groups (A and B) are randomly arranged in each double block. The possible permutations include AB, BA, AA, BB To generate these blocks. The website www.sealedenvelope.com is used, which provides a tool for generating random assignments and random block allocations in clinical studies. This website uses randomization algorithms to generate the required sequence completely randomly and without human intervention. A random list consisting of 37 blocks of double (which totals 74 samples) is created. This random sequence is used to allocate treatment and control groups to the participants, ensuring that the distribution of groups is balanced at each stage.

In this study, all participants, their companions, investigators, and healthcare staff responsible for patient care will remain unaware of the group allocations until the study is completed. This means that the investigator and the individual conducting the sampling, like the participants themselves, will not know which patient is receiving the melatonin or the placebo. Both patients and their companions will also be unaware of the type of pill being given. The drugs and placebos will be coded by someone who is completely blinded to the study process, and the code will be placed in an envelope that indicates whether it's the drug or the placebo. One group will receive drug A, and the other group will receive drug B. Furthermore, the melatonin and placebo tablets, which are identical in color, size, and shape, will be used in the study. Therefore, this will be a double-blind study. The placebo tablets will contain starch and will look, smell, and feel identical to the melatonin tablets.