Randomized Trial of Bicarbonate or Saline Study for the Prevention of Contrast-Induced Nephropathy in Patients with CKD

Abstract

Background and objectives Sodium bicarbonate has been proposed for protection of the kidney from contrastinduced AKI (CIAKI). However, the effects of bicarbonate on long-term important clinical outcomes are uncertain.Design, setting, participants, & measurements In a prospective, double-blind, multicenter randomized clinical trial, 391 patients with an eGFR,45 ml/min per 1.73 m 2 undergoing elective coronary or peripheral angiography were randomized to an infusion with a high dose of isotonic sodium bicarbonate (target 2.0 mEq/kg) or a similar molar amount of isotonic sodium chloride. The primary outcome was a composite of mortality, dialysis, or a sustained 20% reduction in eGFR at 6 months.Results There were 391 patients enrolled between March 2010 and May 2012. The incidence of the primary outcome was 14.9% in the bicarbonate group and 16.3% in the control group in the intention-to-treat population (P=0.78). There was also no difference in the incidence of CIAKI between the treatment groups (14.5% versus 12.1%, respectively; P=0.20). CIAKI was associated with a higher incidence of sustained loss of kidney function at 6 months compared with those without CIAKI (21.2% versus 7.7%, respectively; P=0.06).Conclusions High-dose sodium bicarbonate infusion in patients with eGFR,45 ml/min per 1.73 m 2 undergoing angiography did not demonstrate a difference in incidence of the composite of death, dialysis, or sustained 6-month reduction in eGFR or CIAKI compared with sodium chloride.

Renal dysfunction and the associated decrease in survival after elective endovascular aneurysm repair

“…Recent clinical trials do not support the efficacy of sodium bicarbonate and N -acetylcysteine over crystalloid in preventing renal morbidity. 35-38 The Prevention of Serious Adverse Events Following Angiography (PRESERVE) trial is a large, multicenter randomized trial that is actively recruiting and aimed at defining the optimal approach to protecting renal function 39 ; final data collection is anticipated in March 2016. 40 Regardless, preintervention hydration strategies influence renal dysfunction and are not captured in the VQI database.…”

Contrast-Induced Sustained Kidney Injury

“…2,15,16 But, the contribution of BOSS to the literature in this area may be more importantly directed for defining whether CK-AKI is actually a disease. Unlike other trials in this area, the primary end point was a composite of death, dialysis, or a sustained 20% reduction in estimated glomerular filtration rate at 6 months.…”

“…In the BOSS trial, 21% of patients with 48-hour defined CI-AKI developed a sustained 6-month reduction in estimated glomerular filtration rate as opposed to a 7.5% rate among patients without CI-AKI (P=0.06). 15 Thus, 48-hour CI-AKI should not be seen necessarily as a disease state. Instead, CI-AKI provides us with another clue as to who will actually develop the real disease of contrast injury that would be easily recognizable to a patient-a sustained loss of renal function leading to a higher risk of dialysis.…”

Intravenous Hydration and Contrast‐Induced Acute Kidney Injury: Too Much of a Good Thing?

“…Acetylcysteine initially demonstrated very strong prevention of CI‐AKI, but now, after many years of study and countless trials and meta‐analyses, we are less certain about its protective effect . Sodium bicarbonate fluids were thought to be superior to sodium chloride, but that finding did not appear to hold up to further scrutiny . Antioxidant vitamins have been tested at multiple junctures, but the results are inconclusive .…”

“…8 Sodium bicarbonate fluids were thought to be superior to sodium chloride, 9 but that finding did not appear to hold up to further scrutiny. 10 Antioxidant vitamins have been tested at multiple junctures, but the results are inconclusive. 11 Candidate interventions that have been tested and demonstrated to be either inconclusively protective or unsuccessful for the prevention of contrast nephropathy are almost innumerable.…”