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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Drug: N-Acetyl Cysteine; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Oral Tablet; Placebo Oral Tablet twice daily.
Experimental: NAC Arm; NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.	Drug: N-Acetyl Cysteine; NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.	Day 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in serum creatinine from baseline in both groups	Day 2
Mean change in serum creatinine from baseline in both groups	Day 6
Adverse events of N-Acteyl Cysteine in both groups	Day 6

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: ILBS-Cirrhosis-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No