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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03759158

Enrollment

100

Registered

2018-11-29

Start date

2018-12-01

Completion date

2019-01-15

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhoses

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.

Interventions

DRUGN-Acetyl Cysteine

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

DRUGPlacebo Oral Tablet

Placebo Oral Tablet twice daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Mean change in serum creatinine from baseline in both groups	Day 2
Adverse events of N-Acteyl Cysteine in both groups	Day 6

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026