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

NCT03759158 | Completed

• 1 other identifier: ILBS-Cirrhosis-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhoses

Outcome Measures

Primary Outcomes (1)

• Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.

  Day 2

Secondary Outcomes (3)

• 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

Study Arms (2)

NAC Arm

EXPERIMENTAL

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

Drug: N-Acetyl Cysteine

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

N-Acetyl Cysteine DRUG

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

NAC Arm

Placebo Oral Tablet DRUG

Placebo Oral Tablet twice daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-18-70 years
• Normal kidney parameters (Creatinine below \<1 ,Creatinine clearance \>60)
• Cirrhosis of liver
• eGFR\>60ml/min

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 29, 2018
• Study Start: December 1, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Locations

IN (1)