Effect of N-acetylcysteine on Renal Functioning of Chronic Kidney Diseases(CKD) Patients After General Anesthesia
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|ClinicalTrials.gov 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
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|
|Experimental: sugar pil and saline||
1200 mg orally; 600mg i.v.
Drug: Siran (N-acetylcysteine)
- parameters of kidney function
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 ClinicalTrials.gov identifier (NCT number): NCT01251029
|Contact: Zoya Haitov, MD||972-8-9779466||ZoyaC@asaf.health.gov.il|
|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|
|Study Chair:||Murat Bahar, MD||Assaf-Harofeh Medical Center|