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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Liver Cirrhoses

Treatments: Drug: Placebo Oral Tablet; Drug: N-Acetyl Cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT03759158

ILBS-Cirrhosis-19

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

NAC Arm

Experimental group

Description:

NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.

Treatment:

Drug: N-Acetyl Cysteine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet