Phase 3
Completed N=5,177
Prevention of Serious Adverse Events Following Angiography
Acute Renal Failure · Chronic Kidney Disease · Coronary Artery Disease
Source: ClinicalTrials.gov NCT01467466 ↗
Enrolled (actual)
5,177
Serious AEs
77.4%
Results posted
Nov 2018
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
504citations · ~63 / year
Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine.
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.
Linked Publications
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Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine.
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 |
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) and the linked publication. 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. Informational only — not medical advice.