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

NCT ID: NCT03759158

Last Updated: 2019-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-01-15

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.

Detailed Description

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Conditions

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Liver Cirrhoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAC Arm

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

Group Type EXPERIMENTAL

N-Acetyl Cysteine

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo Oral Tablet twice daily.

Interventions

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N-Acetyl Cysteine

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

Intervention Type DRUG

Placebo Oral Tablet

Placebo Oral Tablet twice daily.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-Cirrhosis-19

Identifier Type: -

Identifier Source: org_study_id

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