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Clinical Trials/NCT03759158
NCT03759158
Completed
Not Applicable

N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial

Institute of Liver and Biliary Sciences, India1 site in 1 country100 target enrollmentDecember 1, 2018

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
January 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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