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

Not Applicable

Completed

• Conditions: Liver Cirrhoses
• Interventions: Drug: N-Acetyl Cysteine; Drug: Placebo Oral Tablet

• Registration Number: NCT03759158
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2018-12-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC Arm	N-Acetyl Cysteine	NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
Placebo	Placebo Oral Tablet	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean change in serum creatinine from baseline in both groups	Day 6
Adverse events of N-Acteyl Cysteine in both groups	Day 6

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India