Phase 3
N=5,177
Prevention of Serious Adverse Events Following Angiography
Acute Renal Failure · Kidney Disease · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01467466 ↗Enrolled (actual)
5,177
Serious AEs
77.4%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride. — 111; 116 Participants — p=0.70
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IV isotonic saline (Drug); IV isotonic bicarbonate (Drug); N-acetylcysteine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride. |
111; 116 | 0.70 |
| PRIMARY Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo. |
115; 112 | 0.86 |
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
Data sourced from ClinicalTrials.gov (NCT01467466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.