Overview

Prevention of Serious Adverse Events Following Angiography

Status:
Completed
Trial end date:
2017-10-17
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VA Office of Research and Development
Collaborator:
The George Institute
Treatments:
Acetylcysteine
N-monoacetylcystine
Polystyrene sulfonic acid
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