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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759158
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Cirrhoses Drug: N-Acetyl Cysteine Drug: Placebo Oral Tablet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: NAC Arm
NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
 Drug: N-Acetyl Cysteine
NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
Placebo Comparator: Placebo Drug: Placebo Oral Tablet
Placebo Oral Tablet twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups. [ Time Frame: Day 2 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759158


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03759158    
Other Study ID Numbers: ILBS-Cirrhosis-19
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes