Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine

The purpose of this study is to determine whether N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients.

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Key information

Conditions

Drug-induced Ototoxicity in Peritoneal Dialysis Patients Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Ear Diseases Infections Intraabdominal Infections Otorhinolaryngologic Diseases Ototoxicity Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Radiation Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erciyes University School of Medicine Department of Nephrology

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

End-stage renal disease
Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient
Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode

Exclusion criteria

Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
Detection of mechanical occlusion of external ear
Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
History of a continuous ambulatory peritoneal dialysis related peritonitis

Treatment and study plan

N-acetylcysteine

Drug

N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: May 27, 2010
Registry last updated: May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed