Sepsis. Gram-negative sepsis, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Patients in the Melatonin Supplement group (Melatonin 3 mg tablet manufactured by Webber Naturals Canada), as soon as possible after confirming the diagnosis of sep
Treatment - Drugs
Placebo
Intervention group: Patients in the Melatonin Supplement group (Melatonin 3 mg tablet manufactured by Webber Naturals Canada), as soon as possible after confirming the diagnosis of sepsis, received me
Control group: Patients in the control group received placebo tablets in the shortest possible time after confirming the diagnosis of sepsis, 2 hours after administration of the nocturnal dietary gava
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients suffering from Sepsis as defined by the definition (Increase of at least 2 points in the Sequential Organ Failure Assessment (SOFA) score in patients with suspected infections relative to the initial score of the patient at the time of admission to the Intensive Care Unit). Patients with age range 18 years and over admitted to General Intensive Care Unit of Sina hospital.
Exclusion criteria
Exclusion criteria: Patients under the age of 18 years Patients with liver dysfunction (liver enzyme more than triple normal) Patients with a history of seizure treated with anticonvulsants Pregnant patients Patients with human immunodeficiency virus (HIV) Patients with organ transplant history People with rheumatologic disease or active autoimmune disease Patients receiving immunosuppressive therapy Patients treated with corticosteroids or initiating the administration of this medication during melatonin therapy Patients undergoing radiation therapy Patients with solid tumors or hematologic malignancies The number of white blood cells is less than 1000 per microliter Patients with a history of melatonin allergy Receiving any medication or supplement with approved anti-oxidant or anti-inflammatory effect or regulation of immune system at the same time . Patients without oro/naso-gastric tube
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Lactate. Timepoint: Once on patient's arrival to the study and again after receiving the last dose of melatonin. Method of measurement: Calorimetric method by Hitachi autoanalyzer 911.;Serum procalcitonin. Timepoint: Once on patient's arrival to the study and again after receiving the last dose of melatonin. Method of measurement: Chromatography method by Kit Elisa.;C-reactive protein. Timepoint: Once on patient's arrival to the study and again after receiving the last dose of melatonin. Method of measurement: Turbodometric method using a special kit in Hitachi autoanalyzer machine 911. | — |
Secondary
| Measure | Time frame |
|---|---|
| Soluble protein 100 B. Timepoint: Once on patient's arrival to the study and again after receiving the last dose of melatonin. Method of measurement: Reaction with antibody and measurement with ELISA kit.;Neuron Specific Enolase. Timepoint: Once on patient's arrival to the study and again after receiving the last dose of melatonin. Method of measurement: Reaction with antibody and measurement with ELISA kit.;Sequential Organ Failure Assessment score. Timepoint: Once on patient's arrival to the study and again after receiving the last dose of melatonin. Method of measurement: Sequential Organ Failure Assessment score questionnaire form.;Simplified therapeutic intervention scoring system. Timepoint: Once on patient's arrival to the study and again after receiving the last dose of melatonin. Method of measurement: Simplified therapeutic intervention scoring system questionnaire form. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHesamoddin Hosseinjani
Tehran University of Medical Sciences
Outcome results
None listed