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Completed

NCT Number: NCT03759158

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.

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Key information

Conditions

Liver Cirrhoses

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetyl cysteine

Drug

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

Placebo oral tablet

Drug

Placebo Oral Tablet twice daily.

Primary outcomes

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

    Time frame: Day 2

Secondary outcomes

  1. Mean change in serum creatinine from baseline in both groups

    Time frame: Day 2

  2. Mean change in serum creatinine from baseline in both groups

    Time frame: Day 6

  3. Adverse events of N-Acteyl Cysteine in both groups

    Time frame: Day 6

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2018
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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