Efficacy Trial of N-Acetylcysteine and Sodium Bicarbonate for the Prevention of Contrast-Induced Acute Kidney Injury (PREKIT)

September 13, 2014 updated by: Daisuke Hachinohe, Tokushukai Medical Group

The Prevention Contrast-Induced Acute Kidney Injury With the Triple Combination of Hydration With Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of intravascular contrast administration in the absence of any alternative causes, or a reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than six hours.

It is the common cause of new hospital-acquired renal insufficiency. The occurrence of CIAKI may be influenced by pre-existing renal insufficiency, diabetic nephropathy, dehydration, congestive heart failure, concurrent administration of nephrotoxic drugs, or the dose and type of contrast media used. Previous studies have shown the independent effectiveness of several agents in preventing CIAKI.

Even now, hydration is crucial for preventing CIAKI. Since CIAKI is presumed to be caused by free radical generation, N-Acetylcysteine, which is a potent free radical scavenger, is shown to be effective in preventing nephropathy. At the same time, because free radical formation is promoted by an acidic environment, bicarbonate, which alkalinizes renal tubular fluid, has been shown to reduce renal involvement.

These days, some studies have shown that hydration with sodium bicarbonate plus N-Acetylcysteine was effective and safe in the prevention of CIAKI. In these studies, bicarbonate was used for both alkalinizing renal tubular fluid and hydration. However, if we want to do hydration, we can use saline and if we want to alkalinize renal tubular fluid, we might use bicarbonate by bolus injection.

Actually, bicarbonate for hydration is prepared at sterile preparation room in a hospital, which is very cumbersome procedure and increase in cost. This is one of the reasons that bicarbonate for hydration use does not become common with wide clinical application.

In past issues, though it differs depending on the level of the renal dysfunction, the probability of CIAKI was 8-33% when hydration was administered, 5-15% when hydration and N-Acetylcysteine were administered, and 1.8-1.9% when bicarbonate and N-Acetylcysteine were administered.

Thus, we can hypothesize the combination of N-Acetylcysteine and bicarbonate will play a complementary role in preventing contrast-induced nephropathy.

This is the rational for this study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

458

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Sapporo City, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • serum creatinine more or equal than 1.1mg/dL
  • procedures using contrast media

Exclusion Criteria:

  • congestive heart failure
  • serum creatinine less than 1.1mg/dl
  • allergy to contrast media
  • preexisting dialysis
  • emergency catheterization
  • recent exposure to contrast within 2 days of the study
  • refuse to entry this study
  • PTRA
  • dialysis after procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physiological Saline and N-Acetylcysteine
Drug: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

All patients receive N-Acetylcysteine(NAC) and sodium chloride. NAC is given orally at a dose of 700mg twice daily, on the day before and on the day of administration of the contrast media, for a total of two days.

154mEq/L of sodium chloride is given intravenously. The initial intravenous bolus is 3ml/kg per hour for 1 hour immediately before contrast injection. And then, patients receive the same fluid at 1ml/kg per hour during the contrast exposure and for 6 hours after the procedure.

In addition, intervention arms receive sodium bicarbonate.1000mEq/L of sodium bicarbonate is given intravenously twice at a dose of 40ml immediately before the contrast exposure and immediately after the procedure.
Active Comparator: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate
Drug: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

All patients receive N-Acetylcysteine(NAC) and sodium chloride. NAC is given orally at a dose of 700mg twice daily, on the day before and on the day of administration of the contrast media, for a total of two days.

154mEq/L of sodium chloride is given intravenously. The initial intravenous bolus is 3ml/kg per hour for 1 hour immediately before contrast injection. And then, patients receive the same fluid at 1ml/kg per hour during the contrast exposure and for 6 hours after the procedure.

In addition, intervention arms receive sodium bicarbonate.1000mEq/L of sodium bicarbonate is given intravenously twice at a dose of 40ml immediately before the contrast exposure and immediately after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of contrast-induced acute kidney injury
Time Frame: within 48 hours
Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of intravascular contrast administration in the absence of any alternative causes, or a reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than six hours.
within 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Requirement of dialysis
Time Frame: 6 months
6 months
Requirement of hospitalization and death
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokushukai Medical Group

Investigators

  • Principal Investigator: Daisuke Hachinohe, MD, Sapporo Higashi Tokushukai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

July 11, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 13, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREKIT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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