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Protective Effect of N-acetylcysteine Against From Ototoxicity

NCT ID: NCT01271088

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-11-30

Brief Summary

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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

Detailed Description

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

Conditions

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Hearing Loss, Extreme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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N-acetylcysteine

N-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics

Control

Vancomycine and/or amikacin alone

Group Type NO_INTERVENTION

N-acetylcysteine

Intervention Type DRUG

N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics

Interventions

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N-acetylcysteine

N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics

Intervention Type DRUG

Other Intervention Names

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NAC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Kocyigit

TC Erciyes University Department of Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ismail Kocyigit, MD

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kocyigit I, Vural A, Unal A, Sipahioglu MH, Yucel HE, Aydemir S, Yazici C, Ilhan Sahin M, Oymak O, Tokgoz B. Preventing amikacin related ototoxicity with N-acetylcysteine in patients undergoing peritoneal dialysis. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2611-20. doi: 10.1007/s00405-014-3207-z. Epub 2014 Jul 30.

Reference Type DERIVED
PMID: 25073872 (View on PubMed)

Other Identifiers

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EUTF 2010/32

Identifier Type: -

Identifier Source: org_study_id