N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Overview
- Phase
- Not Applicable
- Intervention
- N-Acetyl Cysteine
- Conditions
- Liver Cirrhoses
- Sponsor
- Institute of Liver and Biliary Sciences, India
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast imaging for various conditions. The risk associated with the development of CIN are still under evaluation. Even with patients having normal kidney functions there is a risk of contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is cirrhosis is also an avenue which requires more studies and also there is a need for formulation of a Score to predict this CIN. Hence this study is being done to assess the incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age-18-70 years
- •Normal kidney parameters (Creatinine below \<1 ,Creatinine clearance \>60)
- •Cirrhosis of liver
- •eGFR\>60ml/min
Exclusion Criteria
- •Chronic kidney disease
- •H/o anaphylaxis to contrast
- •Prior h/o AKI
- •GFR\<60 ML/MIN
- •Prior H/o TACE/HVPG /Contrast ECHO in the last 4 weeks
Arms & Interventions
NAC Arm
NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
Intervention: N-Acetyl Cysteine
Placebo
Intervention: Placebo Oral Tablet
Outcomes
Primary Outcomes
Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.
Time Frame: Day 2
Secondary Outcomes
- Mean change in serum creatinine from baseline in both groups(Day 6)
- Adverse events of N-Acteyl Cysteine in both groups(Day 6)