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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Long-term outcome of patients treated with prophylactic nesiritide for the prevention of acute kidney injury following cardiovascular surgery.
Clinical Cardiology 2010 April
BACKGROUND: Previously, we reported that the prophylactic use of nesiritide did not reduce the incidence of dialysis or death following cardiovascular (CV) surgery despite reducing the incidence of acute kidney injury (AKI) in the immediate postoperative period. Therefore, we investigated whether the observed renal benefits of nesiritide had any long-term impact on cumulative patient survival and renal outcomes.
METHODS: Participants of the Nesiritide Study, a previously reported prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effect of nesiritide on the incidence of dialysis or death at 21 days in adult patients undergoing high-risk CV surgery, were included in the study. Data of the participants' most recent health and renal function status were obtained using institutional review board-approved patient questionnaires, medical records, and the database of the Social Security Administration.
RESULTS: Data on all 94 patients from the Nesiritide Study were obtained. The mean follow-up period was 20.8 +/- 10.4 months. No differences in cumulative survival between the groups were noted at follow-up (nesiritide 77.7% vs placebo 81.6%, P = 0.798). Patients with in-hospital incidence of AKI had a higher rate of mortality than those with no AKI (AKI 41.4% vs no AKI 10.7%, P = 0.002). However, differences in survival time were not significant between the groups when the analysis was restricted to patients with AKI (nesiritide 16.8 +/- 4 months vs placebo 18.5 +/- 2.3 months, P = 0.729).
CONCLUSIONS: Renoprotection provided by nesiritide in the immediate postoperative period was not associated with improved long-term survival in patients undergoing high-risk CV surgery.
METHODS: Participants of the Nesiritide Study, a previously reported prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effect of nesiritide on the incidence of dialysis or death at 21 days in adult patients undergoing high-risk CV surgery, were included in the study. Data of the participants' most recent health and renal function status were obtained using institutional review board-approved patient questionnaires, medical records, and the database of the Social Security Administration.
RESULTS: Data on all 94 patients from the Nesiritide Study were obtained. The mean follow-up period was 20.8 +/- 10.4 months. No differences in cumulative survival between the groups were noted at follow-up (nesiritide 77.7% vs placebo 81.6%, P = 0.798). Patients with in-hospital incidence of AKI had a higher rate of mortality than those with no AKI (AKI 41.4% vs no AKI 10.7%, P = 0.002). However, differences in survival time were not significant between the groups when the analysis was restricted to patients with AKI (nesiritide 16.8 +/- 4 months vs placebo 18.5 +/- 2.3 months, P = 0.729).
CONCLUSIONS: Renoprotection provided by nesiritide in the immediate postoperative period was not associated with improved long-term survival in patients undergoing high-risk CV surgery.
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