Efficacy Trial of N-Acetylcysteine and Sodium Bicarbonate for the Prevention of Contrast-Induced Acute Kidney Injury
NCT ID: NCT01210456
Last Updated: 2014-09-16
Study Results
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Basic Information
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UNKNOWN
PHASE3
458 participants
INTERVENTIONAL
2009-10-31
2014-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Physiological Saline and N-Acetylcysteine
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.
Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* procedures using contrast media
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Tokushukai Medical Group
OTHER
Responsible Party
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Daisuke Hachinohe
Sapporo Higashi Tokushukai Hospital
Principal Investigators
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Daisuke Hachinohe, MD
Role: PRINCIPAL_INVESTIGATOR
Sapporo Higashi Tokushukai Hospital
Locations
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Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Countries
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References
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Benko A, Fraser-Hill M, Magner P, Capusten B, Barrett B, Myers A, Owen RJ; Canadian Association of Radiologists. Canadian Association of Radiologists: consensus guidelines for the prevention of contrast-induced nephropathy. Can Assoc Radiol J. 2007 Apr;58(2):79-87.
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Goldenberg I, Shechter M, Matetzky S, Jonas M, Adam M, Pres H, Elian D, Agranat O, Schwammenthal E, Guetta V. Oral acetylcysteine as an adjunct to saline hydration for the prevention of contrast-induced nephropathy following coronary angiography. A randomized controlled trial and review of the current literature. Eur Heart J. 2004 Feb;25(3):212-8. doi: 10.1016/j.ehj.2003.11.011.
Shyu KG, Cheng JJ, Kuan P. Acetylcysteine protects against acute renal damage in patients with abnormal renal function undergoing a coronary procedure. J Am Coll Cardiol. 2002 Oct 16;40(8):1383-8. doi: 10.1016/s0735-1097(02)02308-2.
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Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Intern Med. 2008 Feb 19;148(4):284-94. doi: 10.7326/0003-4819-148-4-200802190-00007.
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Other Identifiers
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PREKIT-001
Identifier Type: -
Identifier Source: org_study_id
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