Back to resultsN-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Primary Purpose
Liver Cirrhoses
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
N-Acetyl Cysteine
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhoses
Eligibility Criteria
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NAC Arm
Placebo
Arm Description
NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
Outcomes
Primary Outcome Measures
Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.
Secondary Outcome Measures
Mean change in serum creatinine from baseline in both groups
Mean change in serum creatinine from baseline in both groups
Adverse events of N-Acteyl Cysteine in both groups
Full Information
NCT ID
NCT03759158
First Posted
November 28, 2018
Last Updated
November 1, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03759158
Brief Title
N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Official Title
N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAC Arm
Arm Type
Experimental
Arm Description
NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N-Acetyl Cysteine
Intervention Description
NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo Oral Tablet twice daily.
Primary Outcome Measure Information:
Title
Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Mean change in serum creatinine from baseline in both groups
Time Frame
Day 2
Title
Mean change in serum creatinine from baseline in both groups
Time Frame
Day 6
Title
Adverse events of N-Acteyl Cysteine in both groups
Time Frame
Day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
We'll reach out to this number within 24 hrs