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Effect of N-acetylcysteine on Renal Functioning of Chronic Kidney Diseases(CKD) Patients After General Anesthesia

NCT ID: NCT01251029

Last Updated: 2010-12-01

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

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-31

Brief Summary

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Acute kidney injury (AKI) is one of the most serious and frequent complication of general anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD patients often need some surgical interventions that have been done under general anesthesia; they therefore have an increased probability to develop AKI.

N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties, reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney from injury induced by contrast media, ischemia, and toxins.

Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in renal functioning in CKD patients undergoing major surgery under general anesthesia.

Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40) patients that should undergo surgical interventions under general anesthesia and will divide to 3 groups as follows: group 1- about 40 patients which should undergo major vascular surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B). Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery. Subgroup B will receive placebo (saline).

Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after surgery in all patients. An additional blood samples for assessment of nitric oxide and cytokine levels will be taken from each patient before and after surgery.

Detailed Description

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Conditions

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Chronic Kidney Diseases General Anesthesia

Study Groups

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sugar pil and saline

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

1200 mg orally; 600mg i.v.

Siran (N-acetylcysteine)

Intervention Type DRUG

Interventions

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N-acetylcysteine

1200 mg orally; 600mg i.v.

Intervention Type DRUG

Siran (N-acetylcysteine)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia

Exclusion Criteria

* pregnancy
* single kidney
* heart failure (NYHA class III-IV)
* hepatic failure
* mental diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anesthesiology Department, Assaf Harofeh Medical Center

Principal Investigators

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Murat Bahar, MD

Role: STUDY_CHAIR

Assaf-Harofeh Medical Center

Locations

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Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status

Countries

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Israel

Central Contacts

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Zoya Haitov, MD

Role: CONTACT

Phone: 972-8-9779466

Email: [email protected]

Facility Contacts

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Zoya Haitov, MD

Role: primary

Other Identifiers

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197/10

Identifier Type: -

Identifier Source: org_study_id