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Effect of Injectable N-acetylcysteine in Prevention of Vancomycin-Induced Nephrotoxicity

Comparison of the Effectiveness of Injectable N-acetylcysteine versus Placebo in Prevention of Vancomycin-Induced Nephrotoxicity in Hospitalized Patients: A Double-blind Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241203063930N1
Enrollment
62
Registered
2025-05-22
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Drug-induced acute kidney injury. Acute kidney failure, unspecified

Interventions

Intervention 1: Intervention group: Patients in the intervention group will receive intravenous vancomycin along with injectable N-Acetylcycteine. Vancomycin will be administered with a loading dose o

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years old Receiving vancomycin for at least 5 days Baseline serum creatinine clearance above 30 ml/min at the start of treatment Hospitalized in infectious diseases ward of Shahid Sadoughi Hospital of Yazd Informed consent to participate in the study

Exclusion criteria

Exclusion criteria: History of hypersensitivity to Vancomycin and injectable N-Acetylcyteine Concurrent use of nephrotoxic drugs. Including amphotericin B, aminoglycosides contrast media and NSAIDs Concurrent use of other antioxidants including vitamin C, vitamin E and N-acetylcyctein Body mass index greater than or equal to 3 Receipt of vancomycin within the past 20 days

Design outcomes

Primary

MeasureTime frame
Mean serum creatinine level. Timepoint: In the present study, serum creatinine, serum urea, and creatinine clearance are measured at baseline (before the intervention) and on days 2, 3, 4, and 5 after the intervention. Method of measurement: autoanalyzer.

Secondary

MeasureTime frame
Changes in GFR. Timepoint: Daily from study initiation up to 10 days. Method of measurement: Cockcroft-Gault formula.;Incidence of acute kidney injury. Timepoint: Daily assessment using RIFLE criteria until study completion. Method of measurement: Assessment using RIFLE criteria(Risk, Injury, Failure, Loss, End-stage kidney disease).;Drug adverse effects;. Timepoint: Daily from study initiation up to 10 days. Method of measurement: Assessment using Narenjo scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehri Kalouti

Yazd University of Medical Sciences

mehrikl52@gmail.com+98 912 459 7939

Outcome results

None listed

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