Protective Effect of N-acetylcysteine Against From Ototoxicity

Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and prophylaxis of many diseases related to oxidative stress. The aim of this study was to examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can be prevented by N-acetylcysteine

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Key information

Conditions

Hearing Loss, Extreme Chemically-Induced Disorders Deafness Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Ear Diseases Hearing Disorders Hearing Loss Infections Intraabdominal Infections Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Ototoxicity Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Radiation Injuries Sensation Disorders Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

About this study

NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.

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
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 a day,one week after administration of antibiotics

Other names: NAC

Primary outcomes

Threshold hearing levels

Time frame: 4 weeks

Ototoxicity was defined as an increase in the auditory threshold by at least 20 dB at any one test frequency, or at least 10 dB at any two adjacent frequencies, or loss of response at three consecutive frequencies between the baseline and follow-up studies in the worse ear.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 6, 2011
Registry last updated: Nov 16, 2011

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.

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