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

Liver Cirrhoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759158
• Other study ID #: ILBS-Cirrhosis-19
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: November 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

Drug:
• N-Acetyl Cysteine
NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
• Placebo Oral Tablet
Placebo Oral Tablet twice daily.

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.		Day 2
Secondary	Mean change in serum creatinine from baseline in both groups		Day 2
Secondary	Mean change in serum creatinine from baseline in both groups		Day 6
Secondary	Adverse events of N-Acteyl Cysteine in both groups		Day 6