search
Back to results

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

Primary Purpose

Chronic Kidney Diseases, General Anesthesia

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
N-acetylcysteine
Siran (N-acetylcysteine)
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sugar pil and saline

Arm Description

Outcomes

Primary Outcome Measures

parameters of kidney function

Secondary Outcome Measures

Full Information

First Posted
November 25, 2010
Last Updated
November 30, 2010
Sponsor
Assaf-Harofeh Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01251029
Brief Title
Effect of N-acetylcysteine on Renal Functioning of Chronic Kidney Diseases(CKD) Patients After General Anesthesia
Official Title
Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, General Anesthesia

7. Study Design

Study Phase
Phase 1

8. Arms, Groups, and Interventions

Arm Title
sugar pil and saline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
1200 mg orally; 600mg i.v.
Intervention Type
Drug
Intervention Name(s)
Siran (N-acetylcysteine)
Primary Outcome Measure Information:
Title
parameters of kidney function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoya Haitov, MD
Phone
972-8-9779466
Email
ZoyaC@asaf.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Bahar, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoya Haitov, MD
Phone
972-8-9779946
Email
ZoyaC@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
Zoya Haitov, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs