Evaluation of melatonin efficacy in prevention of colistin induced nephrotoxicity

Evaluation of melatonin tablet efficacy in prevention of colistin induced nephrotoxicity in hospitalized patients in ICU

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200408046990N16

Enrollment

Registered

2024-09-06

Start date

2024-08-22

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Patients treated with colistin. Other systemic antibiotics

Interventions

Intervention 1: Intervention group: Intervention group will receive two tablets each containing 10 mg of melatonin for 10 days during course of colistin treatment. Intervention 2: Control group: The c

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years No simultaneous use of fluvoxamine and other nephrotoxic drugs except nephrotoxic antimicrobials (vancomycin, aminoglycoside, amphotericin) Signing a written informed consent

Exclusion criteria

Exclusion criteria: glomerular filtration rate less than 60 ml/min pregnancy or lactation allergy history to melatonin Hospitalization in the intensive care unit

Design outcomes

Primary

Measure	Time frame
Acute Kidney Injury (increase of 0.3 mg/dl in creatinine for two consecutive days). Timepoint: Every other day (3 times a week). Method of measurement: Measurement of serum creatinine level and blood urea nitrogen level and evaluation of acute kidney injury based on Acute Kidney Injury Network/Kidney Disease: Improving Global Outcomes criteria.;Serum creatinine and BUN levels. Timepoint: Every other day (3 times a week). Method of measurement: Serum level measurement by the laboratory.	—

Measure

Time frame

Acute Kidney Injury (increase of 0.3 mg/dl in creatinine for two consecutive days). Timepoint: Every other day (3 times a week). Method of measurement: Measurement of serum creatinine level and blood urea nitrogen level and evaluation of acute kidney injury based on Acute Kidney Injury Network/Kidney Disease: Improving Global Outcomes criteria.;Serum creatinine and BUN levels. Timepoint: Every other day (3 times a week). Method of measurement: Serum level measurement by the laboratory.

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Secondary

Measure	Time frame
SOFA Score. Timepoint: At the beginning of the study andAt the end of a week from the beginning. Method of measurement: Laboratory findings and clinical examination.;Vital Signs. Timepoint: every day. Method of measurement: clinical examination.;APACHE SCORE. Timepoint: At the beginning of the study and at the end of a week. Method of measurement: clinical examination.;White blood cell count. Timepoint: At the beginning of the study and at the end of a week. Method of measurement: laboratory findings.;CRP serum level. Timepoint: At the beginning of the study and at the end of a week. Method of measurement: Serum level measurement.;Procalcitonin serum level. Timepoint: At the beginning of the study and after ten days of taking melatonin tablets. Method of measurement: Serum level measurement.	—

Measure

Time frame

SOFA Score. Timepoint: At the beginning of the study andAt the end of a week from the beginning. Method of measurement: Laboratory findings and clinical examination.;Vital Signs. Timepoint: every day. Method of measurement: clinical examination.;APACHE SCORE. Timepoint: At the beginning of the study and at the end of a week. Method of measurement: clinical examination.;White blood cell count. Timepoint: At the beginning of the study and at the end of a week. Method of measurement: laboratory findings.;CRP serum level. Timepoint: At the beginning of the study and at the end of a week. Method of measurement: Serum level measurement.;Procalcitonin serum level. Timepoint: At the beginning of the study and after ten days of taking melatonin tablets. Method of measurement: Serum level measurement.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Elyasi

Mashhad University of Medical Sciences

elyasis@mums.ac.ir+98 51 3180 1588

Outcome results

None listed

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