The effect of melatonin and N-acetyl cysteine on colistin-associated nephrotoxicity

Evaluation of the protective effect of melatonin and N-acetyl cysteine on colistin-induced nephrotoxicity in critically ill patients: A randomized, controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150221021159N3

Enrollment

Registered

2020-06-23

Start date

2018-12-09

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Acute kidney failure. Acute kidney failure, unspecified

Interventions

Intervention 1: First intervention group: Melatonin tablets made in nature made company are administered orally at the dose of 3 mg twice daily for 5 days, on the same date of starting colistin. Inter

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients (more than 18 years) who received intravenous colistin. Creatinine clearance = 45 ml/min at study recruitment Oral tolerance to the drug

Exclusion criteria

Exclusion criteria: Receiving intravenous collistin or melatonin for at least 2 weeks before study recruitment Acute kidney injury before study recruitment

Design outcomes

Primary

Measure	Time frame
Acute kidney failure based on changes of urinary Neutrophil gelatinase-associated lipoccalin (NGAL) and serum creatinine levels. Timepoint: Measurement of urinary NGAL and serum creatinine at the initial of study (before initiation of colistin or intervention) and 5 days after intervention. Method of measurement: ELISA Kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadi Farsaei

Esfahan University of Medical Sciences

Farsaei@pharm.mui.ac.ir+98 31 3792 7071

Outcome results

None listed

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