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 with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients.
CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE)
The intravascular administration of iodinated contrast media for diagnostic imaging is a common cause of acute kidney injury (AKI) and a leading cause of iatrogenic renal disease. Contrast-induced AKI is associated with serious adverse outcomes including death, need for dialysis, prolonged hospitalization, and acceleration in the rate of progression of underlying chronic kidney disease. The benefit of IV isotonic bicarbonate compared to IV isotonic saline and of N-acetylcysteine for the prevention of contrast-induced AKI and associated adverse outcomes remains unclear. The purpose of this trial is to compare the effectiveness of IV isotonic sodium bicarbonate with IV isotonic sodium chloride and oral NAC with placebo for the prevention of serious adverse outcomes in 7,680 high-risk patients scheduled to undergo coronary or non-coronary angiography. Using a 2 x 2 factorial design, patients will be randomized to receive: 1) either peri-procedural IV isotonic sodium bicarbonate or peri-procedural IV isotonic saline and 2) either oral NAC or oral placebo prior to and for 5 days following the angiographic procedure. The primary study endpoint is a composite outcome comprised of death, need for acute dialysis, or persistent decline in kidney function within 90 days following the index angiogram.
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
You CAN'T join if...
Stage 5 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 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
Age <18 years
Ongoing participation in an unapproved concurrent interventional study
San Francisco VA Medical Center, San Francisco, CA San Francisco, California, 94121, United States
VA Palo Alto Health Care System, Palo Alto, CA Palo Alto, California, 94304-1290, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles, California, 90073, United States