PRESERVE (sodium bicarbonate)
Trial question
What is the role of sodium bicarbonate in patients at high risk for renal complications who were undergoing angiography?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
6.0% female
94.0% male
N = 4993
4993 patients (322 female, 4671 male).
Inclusion criteria: patients at high risk for renal complications who were scheduled to undergo angiography.
Key exclusion criteria: patients undergoing emergency angiography; unstable baseline levels of blood creatinine.
Interventions
N=2511 sodium bicarbonate (IV 1.26% sodium bicarbonate).
N=2482 sodium chloride (IV 0.9% sodium chloride).
Primary outcome
Death, need for dialysis, or a persistent elevation of serum creatinine level by at least 50% from baseline at day 90
4.4%
4.7%
4.7 %
3.5 %
2.4 %
1.2 %
0.0 %
Sodium
bicarbonate
Sodium
chloride
No significant
difference ↔
No significant difference in death, need for dialysis, or a persistent elevation of serum creatinine level by at least 50% from baseline at day 90 (4.4% vs. 4.7%; OR 0.93, 95% CI 0.72 to 1.22).
Secondary outcomes
No significant difference in contrast-associated AKI (9.5% vs. 8.3%; OR 1.16, 95% CI 0.96 to 1.41).
No significant difference in the rate of death by day 90 (2.4% vs. 2.7%; OR 0.87, 95% CI 0.61 to 1.24).
No significant difference in the rate of need for dialysis by day 90 (1.3% vs. 1.2%; OR 1.09, 95% CI 0.65 to 1.81).
Conclusion
In patients at high risk for renal complications who were scheduled to undergo angiography, sodium bicarbonate was not superior to sodium chloride with respect to death, need for dialysis, or a persistent elevation of serum creatinine level by at least 50% from baseline at day 90.
Reference
Steven D Weisbord, Martin Gallagher, Hani Jneid et al. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine. N Engl J Med. 2018 Feb 15;378(7):603-614.
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