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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251029
Recruitment Status : Unknown
Verified November 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2010
Last Update Posted : December 1, 2010
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases General Anesthesia Drug: N-acetylcysteine Drug: Siran (N-acetylcysteine) Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia
Study Start Date : January 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: sugar pil and saline Drug: N-acetylcysteine
1200 mg orally; 600mg i.v.

Drug: Siran (N-acetylcysteine)

Primary Outcome Measures :
  1. parameters of kidney function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251029

Contact: Zoya Haitov, MD 972-8-9779466

Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Zoya Haitov, MD    972-8-9779946   
Principal Investigator: Zoya Haitov, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Study Chair: Murat Bahar, MD Assaf-Harofeh Medical Center

Responsible Party: Dr. Bahar Murat, MD, Anesthesiology Department, Assaf Harofeh Medical Center Identifier: NCT01251029     History of Changes
Other Study ID Numbers: 197/10
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs