Volume 138, Issue 4 , Pages 959-964, October 2009
Prophylactic nesiritide does not prevent dialysis or all-cause mortality in patients undergoing high-risk cardiac surgery
Objectives
Natriuretic peptides have been shown to improve renal blood flow and stimulate natriuresis. In a recent retrospective trial, we documented that prophylactic use of nesiritide was associated with a 66% reduction in the odds for dialysis or in-hospital mortality at 21 days in patients undergoing high-risk cardiac surgery; therefore, we designed a prospective trial.
Methods
This prospective, randomized, clinical trial included 94 patients undergoing high-risk cardiac surgery comparing a 5-day course of continuous nesiritide (at a dose of 0.01 μg · kg−1 · min−1 started before surgery) versus placebo. The primary end point was dialysis and/or all-cause mortality within 21 days; secondary end points were incidence of acute kidney injury, renal function, and length of stay.
Results
Nesiritide did not reduce the primary end point of incidence of dialysis and/or all-cause mortality through day 21 (6.6% vs 6.1%; P = .914). Fewer patients receiving nesiritide had acute kidney injury (defined as an absolute increase in serum creatinine ≥ 0.3 mg/dL from baseline or a percentage increase in serum creatinine ≥ 50% from baseline within 48 hours) compared with controls (2.2% vs 22.4%; P = .004), and mean serum creatinine was lower in the immediate postoperative period in the nesiritide group (1.18 ± 0.41 mg/dL vs 1.45 ± 0.74 mg/dL; P = .028). However, no difference in length of stay was noted (nesiritide 20.73 ± 3.05 days vs control 21.26 ± 4.03 days; P = .917).
Conclusions
These results do not demonstrate a benefit for prophylactic use of nesiritide on the incidence of dialysis and/or death in patients undergoing high-risk cardiac surgery. Although nesiritide may provide some renal protection in the immediate postoperative period, no effect on length of stay was observed.
Abbreviations and Acronyms: AKI, acute kidney injury, AKI0.3mg/dL, absolute increase in serum creatinine of more than or equal to 0.3 mg/dL from baseline, AKI50%, increase in serum creatinine of more than or equal to 50% from baseline within 48 hours, CI, confidence interval, GFR, glomerular filtration rate, MDRD, Modification of Diet in Renal Disease, OR, odds ratio, RRT, renal replacement therapy, SCr, serum creatinine
CTSNet classification: 18
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Disclosures: The study was conducted under an investigator-proposed research grant from Scios, Inc. The authors do not have any other conflict of interest.
Clinical trials registration:ClinicalTrials.gov NCT00110201.
PII: S0022-5223(09)00712-0
doi:10.1016/j.jtcvs.2009.05.014
© 2009 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Volume 138, Issue 4 , Pages 959-964, October 2009
