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Study aim
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To assess the effect of melatonin versus placebo on serum levels of oxidative stress biomarkers and clinical outcomes in patients with septic shock
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Design
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This is a double-blind randomized clinical trial, phase II, in which 40 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients with septic shock who will refer to Besat Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 65 years,
Septic shock,
Exclusion criteria:
Pregnancy or breastfeeding,
Contraindication of intestinal nutrition,
Using other antioxidants or anti-inflammatory drugs,
Liver or renal chronic diseases
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Intervention groups
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Intervention group:
Routine treatment plus oral melatonin 50 mg made by Sepidteb Pharmaceutical Factory daily for 5 days through a nasogastric tube
Control group:
Routine treatment plus oral placebo made by the laboratory of the Hamadan School of Pharmacy daily for 5 days through a nasogastric tube
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Main outcome variables
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Primary outcome:
Catalase activity,
Superoxide dismutase activity,
Glutathione peroxidase activity,
Malondialdehyde activity,
The occurrence of death,
Duration of mechanical ventilation,
Duration of hospitalization,
The average dose of vasopressor