Investigating the Effect of Melatonin on Mortality and Morbidity of Sepsis Patients in ICU

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150706023084N22

Enrollment

Registered

2024-10-01

Start date

2024-10-16

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Sepsis. Sepsis, unspecified organism

Interventions

Intervention 1: Intervention group: Gavage of 50 mg of Melatonin at Night for 5 Consecutive Nights. Intervention 2: Control group: placebo.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Sepsis Patients in ICU

Exclusion criteria

Exclusion criteria: pregnancy breastfeeding

Design outcomes

Primary

Measure	Time frame
Mortality and Morbidity of Patients Based on SOFA Score. Timepoint: At the Beginning of the Study and 5 Days after Melatonin Administration. Method of measurement: Calculation of SOFA score.;Mortality and Morbidity of Patients Based on APACHE II Score. Timepoint: At the Beginning of the Study and 5 Days after Melatonin Administration. Method of measurement: Calculation of APACHE II Score.;Erythrocyte Sedimentation Rate (ESR). Timepoint: At the Beginning of the Study and 5 Days after Melatonin Administration. Method of measurement: Blood Test.	—

Measure

Time frame

Mortality and Morbidity of Patients Based on SOFA Score. Timepoint: At the Beginning of the Study and 5 Days after Melatonin Administration. Method of measurement: Calculation of SOFA score.;Mortality and Morbidity of Patients Based on APACHE II Score. Timepoint: At the Beginning of the Study and 5 Days after Melatonin Administration. Method of measurement: Calculation of APACHE II Score.;Erythrocyte Sedimentation Rate (ESR). Timepoint: At the Beginning of the Study and 5 Days after Melatonin Administration. Method of measurement: Blood Test.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Shiehmorteza

Islamic Azad University

shiehmorteza@iaups.ac.ir+98 21 2264 0056

Outcome results

None listed

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