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

Phase 1

• Conditions: Chronic Kidney Diseases; General Anesthesia
• Interventions: Drug: N-acetylcysteine; Drug: Siran (N-acetylcysteine)

• Registration Number: NCT01251029
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-25
• Study First Submitted QC: 2010-11-30
• Last Update Submitted: 2010-11-30
• Study First Posted: 2010-12-01
• Last Update Posted: 2010-12-01
• Study Start: 2011-01
• Primary Completion: 2013-09
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sugar pil and saline	Siran (N-acetylcysteine)	-
sugar pil and saline	N-acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
parameters of kidney function

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel