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

Evaluation of the effect of melatonin on inflammatory factors and clinical outcomes in sepsis patients hospitalized in the Intensive Care Unit

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181104041551N4

Enrollment

Registered

2024-02-01

Start date

2024-02-09

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis. Other sepsis

Interventions

Intervention 1: Intervention group: Melatonin with a dose of 15 mg per day. It should be noted that the routine treatment of patients (such as receiving antibiotics, conventional supportive treatments

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fatemeh Heydari

Mazandaran University of Medical Sciences

f.heydari@mazums.ac.ir+98 11 3335 0672

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026