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Studying the effect of melatonin on colistin-induced acute kidney injury

Effect of melatonin on serum creatinine in patients admitted to the intensive care unit: a randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240220061059N7
Enrollment
40
Registered
2025-08-26
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Renal disease. Acute kidney failure

Interventions

Intervention 1: Intervention group: The recipient received the oral form (oral or gavage) of melatonin 3 mg tablets manufactured by Razak Company, 3 tablets every 8 hours, starting from the first day

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: age above 18 years Glomerular Filtration Rate more than 30 ml/min received colistin during less 48 hours of admission

Exclusion criteria

Exclusion criteria: Patients undergoing peritoneal or hemodialysis Receiving melatonin 2 weeks before hospitalization Receiving colistin 2 weeks before hospitalization pregnant or breast feeding women Allergy or side effects with melatonin Patients unable to take medications via the gastrointestinal tract since starting colistin(NPO)

Design outcomes

Primary

MeasureTime frame
Daily serum creatinine level. Timepoint: Serum creatinine levels measured daily from the first day to the last day of colistin administration and for at least 5 days. Method of measurement: By taking a sample of the patient's blood and reading serum creatinine using a laboratory device.

Secondary

MeasureTime frame
Review and comparison of acute kidney injury with KDIGO criteria. Timepoint: KDIGO criteria AKI is considered to be an increase of greater than or equal to 0.3 mg/dl in serum creatinine for at least 48 hours, or an increase of 50% or more from baseline for at least 7 days, or a decrease in urine output below 6 cc/kg/hour for 6 hours. Method of measurement: To assess the secondary outcome, which is acute kidney injury based on the KDIGO criteria, serum creatinine in mg/mL and urine volume in mL are used.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGolnaz Afzal

Yazd University of Medical Sciences

dr.golnaz.afzal@gmail.com+98 912 449 8211

Outcome results

None listed

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