Evaluation of The Effect of N-acetylcysteine in The Prevention of Vancomycin-Induced Renal Disorder

Evaluation of the effectiveness of N-acetylcysteine in the prevention of colistin-induced nephrotoxicity: a randomized controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150721023282N6

Enrollment

Registered

2019-12-19

Start date

2019-09-22

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: N-acetylcysteine, 600 mg, twice daily, for 10 days, PO. Intervention 2: Control group: Without intervention.

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Take colistin at a dose of 4.5 million units every 12 hours Creatinine Clearance > 90 ml/min (Based on CKD-EPI Formula)

Exclusion criteria

Exclusion criteria: Underlying kidney disorder Receiving other nephrotoxic drugs

Design outcomes

Primary

Measure	Time frame
Serum Creatinine. Timepoint: At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention. Method of measurement: Spectrophotometry.;Blood Urea Nitrogen. Timepoint: At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention. Method of measurement: Spectrophotometry.;Creatinine Clearance. Timepoint: At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention. Method of measurement: CKD-EPI Formula.;NGAL serum level. Timepoint: At baseline and 5 days after initiation of intervention. Method of measurement: NGAL Measurement Kit.;The number of patients with acute kidney injury. Timepoint: End of intervention. Method of measurement: counting.	—

Measure

Time frame

Serum Creatinine. Timepoint: At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention. Method of measurement: Spectrophotometry.;Blood Urea Nitrogen. Timepoint: At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention. Method of measurement: Spectrophotometry.;Creatinine Clearance. Timepoint: At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention. Method of measurement: CKD-EPI Formula.;NGAL serum level. Timepoint: At baseline and 5 days after initiation of intervention. Method of measurement: NGAL Measurement Kit.;The number of patients with acute kidney injury. Timepoint: End of intervention. Method of measurement: counting.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasool Soltani

Esfahan University of Medical Sciences

soltani@pharm.mui.ac.ir+98 31 3786 5537

Outcome results