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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Cirrhoses

Intervention / Treatment
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* Drug: N-Acetyl Cysteine
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC Arm<br>NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure. | Drug: N-Acetyl Cysteine<br>* NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo Oral Tablet<br>* Placebo Oral Tablet twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups. |  | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |