Prevention of Serious Adverse Events Following Angiography
Condition: Acute Renal Failure; Kidney Disease; Coronary Artery Disease
MeSH terms: Kidney Diseases; Acute Kidney Injury; Coronary Artery Disease
Intervention: IV isotonic saline; IV isotonic bicarbonate; N-acetylcysteine; Placebo
Intervention description: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.; The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.; NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.; A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal; cardiovascular; kidney; heart; clinical trial; double-blind; multi-site trial; randomized; drug treatment; IV solutions; antioxidant

Summary:

      The purpose of this research study is to compare the effectiveness of intravenous isotonic
      sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine (NAC)
      with oral placebo for the prevention of serious adverse outcomes following angiographic
      procedures in high-risk patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned elective or urgent coronary or non-coronary angiography with iodinated
             contrast media in which it is anticipated that there will be an interval of 3 hours
             between the identification of the indication for angiography and the time of the
             planned procedure.

          -  Pre-angiography eGFR <60 ml/min/1.73 m2 with diabetes mellitus or pre-angiography eGFR
             <45 ml/min/1.73 m2 with or without diabetes mellitus

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Stage 5 chronic kidney disease (CKD) (eGFR <15 mL/min/1.73 m2)

          -  Currently receiving hemodialysis, peritoneal dialysis, continuous renal replacement
             therapy, or sustained low efficiency dialysis (SLED)

          -  Unstable baseline serum creatinine (SCr) (if known) at the time of angiography defined
             by an increase in SCr of 25% over the 3 days prior to angiography

          -  Decompensated heart failure requiring any of the following therapies at the time of
             angiography:

               -  IV milrinone, amrinone, dobutamine, or nesiritide

               -  Isolated ultrafiltration therapy

               -  Intra-aortic balloon pump

          -  Emergent angiography procedures defined as an anticipated duration of <3 hours between
             the identification of the indication for angiography and the time of the planned
             procedure.

          -  Receipt of intravascular iodinated contrast within the 5 days preceding angiography

          -  Receipt of oral or IV NAC within the 48 hours preceding angiography

          -  Known allergy to N-acetylcysteine (NAC)

          -  Known anaphylactic allergy to iodinated contrast media

          -  Prisoner

          -  Age <18 years

          -  Pregnancy

          -  Ongoing participation in an unapproved concurrent interventional study