Roger E. Dionne

Initial experience with fenoldopam after cardiac surgery in neonates with an insufficient response to conventional diuretics.

Objective: Fenoldopam, a selective dopamine-1 receptor agonist, causes systemic vasodilation and increased renal blood flow and tubular sodium excretion. We hypothesized that urine output would improve when fenoldopam was added to conventional diuretic therapy after neonatal cardiopulmonary bypass. Design: Retrospective cohort study using a time-series design. Setting: Pediatric cardiac intensive care unit. Patients: All neonates who received fenoldopam to promote diuresis after cardiac surgery requiring cardiopulmonary bypass from February 2002 through December 2004. Interventions: Fenoldopam infusion for inadequate urine output despite conventional diuretics. Measurements: Demographics, diagnostic information, and surgical procedures were recorded. Urine output, fluid balance, inotrope scores, diuretic doses, and other clinical variables that may influence diuresis were recorded for the 24-hr period immediately preceding fenoldopam initiation and during the initial 24 hrs of drug administration. Main Results: A total of 25 neonates received fenoldopam to promote diuresis after the modified Norwood (n = 14), arterial switch (n = 4), or other operations (n = 7). Heart rate, conventional diuretic dosing, and fluid intake were similar during the 24-hr periods of conventional therapy and fenoldopam use (p = not significant for all), whereas inotrope scores decreased during the study (p = .021). There was a small but statistically significant increase in blood pressure during the 48-hr study period. Median urine output was 3.6 mL·kg−1·hr−1 (range, 0.2–7.2 mL·kg−1·hr−1) during the 24-hr period of conventional therapy and 5.8 mL·kg−1·hr−1 (range, 1.6–11.7 mL·kg−1·hr−1) during the initial 24 hrs of fenoldopam administration (Wilcoxons signed-rank test, p = .001). Conclusions: Fenoldopam may improve urine output in neonates who are failing to achieve an adequate negative fluid balance despite conventional diuretic therapy after cardiac surgery and cardiopulmonary bypass. This study is limited by its retrospective design and the possibility that urine output improved spontaneously during the treatment period. A randomized, placebo-controlled clinical trial will be required to confirm these findings.

Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery After Fontan SurgeryCLINICAL PERSPECTIVE

Background—We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. Methods and Results—In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ⩽5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0–24]; milrinone, 18 [0–23]; placebo, 20 [0–23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Conclusions—Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00543309.

Impact of empiric nesiritide or milrinone infusion on early postoperative recovery after Fontan surgery: a randomized, double-blind, placebo-controlled trial.

Background—We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. Methods and Results—In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ⩽5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0–24]; milrinone, 18 [0–23]; placebo, 20 [0–23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Conclusions—Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00543309.

Electronic medication reconciliation and medication errors

OBJECTIVE To measure the impact of electronic medication reconciliation implementation on reports of admission medication reconciliation errors (MREs). DESIGN Quality improvement project with time-series design. SETTING A large, urban, tertiary care childrens hospital. PARTICIPANTS All admitted patients from 2011 and 2012. INTERVENTIONS Implementation of an electronic medication reconciliation tool for hospital admissions and regular compliance reporting to inpatient units. The tool encourages active reconciliation by displaying the pre-admission medication list and admission medication orders side-by-side. MAIN OUTCOME MEASURE Rate of non-intercepted admission MREs identified via a voluntary reporting system. RESULTS During the study period, there were 33 070 hospital admissions. The pre-admission medication list was consistently recorded electronically throughout the study period. In the post-intervention period, the use of the electronic medication reconciliation tool increased to 84%. Reports identified 146 admission MREs during the study period, including 95 non-intercepted errors. Pre- to post-intervention, the rate of non-intercepted errors decreased by 53% (P = 0.02). Reported errors were categorized as intercepted potential adverse drug events (ADEs) (35%), non-intercepted potential ADEs (42%), minor ADEs (22%) or moderate ADEs (1%). There were no reported MREs that resulted in major or catastrophic ADEs. CONCLUSIONS We successfully implemented an electronic process for admission medication reconciliation, which was associated with a reduction in reports of non-intercepted admission MREs.

Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery following Fontan Surgery: A Randomized, Double-blind, Placebo-Controlled Trial

Background—We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. Methods and Results—In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ⩽5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0–24]; milrinone, 18 [0–23]; placebo, 20 [0–23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Conclusions—Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00543309.

Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery After Fontan SurgeryCLINICAL PERSPECTIVE: A Randomized, Double-Blind, Placebo-Controlled Trial

Background—We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. Methods and Results—In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ⩽5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0–24]; milrinone, 18 [0–23]; placebo, 20 [0–23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Conclusions—Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00543309.