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

NCT01251029 | Unknown Phase 1

• 1 other identifier: 197/10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• parameters of kidney function

Study Arms (1)

sugar pil and saline

EXPERIMENTAL

Drug: N-acetylcysteine; Drug: Siran (N-acetylcysteine)

Interventions

N-acetylcysteine DRUG

1200 mg orally; 600mg i.v.

sugar pil and saline

Siran (N-acetylcysteine) DRUG

sugar pil and saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia

You may not qualify if:

• pregnancy
• single kidney
• heart failure (NYHA class III-IV)
• hepatic failure
• mental diseases

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Murat Bahar, MD

  Assaf-Harofeh Medical Center

  STUDY CHAIR

Central Study Contacts

Zoya Haitov, MD

CONTACT

972-8-9779466; ZoyaC@asaf.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: December 1, 2010
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

IL (1)