A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate

NCT00579995 | Terminated Results

• 1 other identifier: 0120-05-FB
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.

Conditions

Nephropathy

Keywords

contrast induced nephropathy

Outcome Measures

Primary Outcomes (1)

• Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy

  Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.

  2 years

Study Arms (2)

N-Acetylcysteine

ACTIVE COMPARATOR

Oral N-Acetylcysteine 600 mg

Drug: Oral N-Acetylcysteine

Sodium Bicarbonate

ACTIVE COMPARATOR

Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure

Drug: Sodium Bicarbonate

Interventions

Oral N-Acetylcysteine DRUG

600 milligrams (mg)

Also known as: N-Acetyl-L-Cysteine

N-Acetylcysteine

Sodium Bicarbonate DRUG

3 milliliters per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure

Also known as: Sodium hydrogen carbonate, sodium acid carbonate, baking soda

Sodium Bicarbonate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Baseline serum creatinine or
• Calculated creatinine
• Stable Renal Function
• Left Ventricular ejection fraction
• Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required
• Able to sign informed consent

You may not qualify if:

• Acute renal failure
• History of Kidney transplant
• Currently receiving N-acetylcysteine
• \_ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate
• Left ventricular ejection fraction
• Pregnant, lactating females
• Allergy to contrast dye

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Acetylcysteine; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data. Rate of 72 hour Creatinine determination was poor.

Results Point of Contact

• Title: Scott Shurmur, M.D.
• Organization: University of Nebraska Medical Center

sshurmur@unmc.edu

402-559-6463

Study Officials

• Scott Shurmur, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: May 1, 2005
• Primary Completion: April 8, 2010
• Study Completion: April 8, 2010
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Locations

US (1)