Evaluation of the effect of Melatonin in Sepsis

Phase 3

Recruiting

• Conditions: Sepsis.; Gram-negative sepsis, unspecified; A41.50

• Registration Number: IRCT20171104037228N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.