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

NCT01210456 | Unknown Phase 3

• 1 other identifier: PREKIT-001
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Contrast Media; Acute Kidney Injury; N-Acetylcysteine; Bicarbonate

Outcome Measures

Primary Outcomes (1)

• Development of contrast-induced acute kidney injury

  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 Outcomes (2)

• Requirement of dialysis

  6 months

• Requirement of hospitalization and death

  6 months

Study Arms (2)

Physiological Saline and N-Acetylcysteine

ACTIVE COMPARATOR

Drug: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

ACTIVE COMPARATOR

Drug: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

Interventions

Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate DRUG

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 and N-Acetylcysteine; Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokushukai Medical Group: lead

Study Sites (1)

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, 065-0033, Japan

Location

Related Publications (28)

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury

Interventions

Acetylcysteine; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daisuke Hachinohe, MD

  Sapporo Higashi Tokushukai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sapporo Higashi Tokushukai Hospital

Study Record Dates

• First Submitted: July 11, 2010
• First Posted: September 28, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

JP (1)