Prophylactic nesiritide does not prevent dialysis or all-cause mortality in patients undergoing high-risk cardiac surgery

Abstract

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 microg x kg(-1) x 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 > or = 0.3 mg/dL from baseline or a percentage increase in serum creatinine > or = 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.

Trial registration: ClinicalTrials.gov NCT00110201.