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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01251029
First received: November 25, 2010
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Chronic Kidney Diseases
General Anesthesia
Drug: N-acetylcysteine
Drug: Siran (N-acetylcysteine)
Phase 1

Study Type: Interventional
Official Title: Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • parameters of kidney function

Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sugar pil and saline Drug: N-acetylcysteine
1200 mg orally; 600mg i.v.
Drug: Siran (N-acetylcysteine)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251029

Contacts
Contact: Zoya Haitov, MD 972-8-9779466 ZoyaC@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Zoya Haitov, MD    972-8-9779946    ZoyaC@asaf.health.gov.il   
Principal Investigator: Zoya Haitov, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Chair: Murat Bahar, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Dr. Bahar Murat, MD, Anesthesiology Department, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01251029     History of Changes
Other Study ID Numbers: 197/10
Study First Received: November 25, 2010
Last Updated: November 30, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014