Evaluation of the effect of melatonin on inflammatory factors and clinical outcomes in sepsis

Phase 3

Recruiting

• Conditions: sepsis.; Other sepsis

• Registration Number: IRCT20181104041551N4
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.