Skip to main content

Table 3 Pre-specified clinical outcomes

From: Prophylactic use of levosimendan in pediatric patients undergoing cardiac surgery: a prospective randomized controlled trial

OutcomeLevosimendan group (n = 94)Placebo group (n = 93)OR (95% CI)p value
Primary outcome
 Incidence of LCOS, n (%)10 (10.6%)18 (19.4%)0.46 (0.19–1.13)0.090
Second outcomes
 90-day mortality, n (%)3 (3.2%)4 (4.3%)0.72 (0.14–3.69)0.693
 Rehospitalization at 90 days, n (%)3 (3.2%)1 (1.1%)2.57 (0.24–27.33)0.433
 Duration of mechanical ventilation (h)47.5 (21.4, 96.0)39.5 (18.0, 97.3)0.532
 Duration of ICU stay (h)114.5 (72.38, 189)118 (69, 200.25)0.442
 Duration of hospital stay (days)20 (17, 27)20 (17, 26)0.806
 Sepsis, n (%)4 (4.3%)6 (6.5%)0.64 (0.18–2.36)0.512
 Pneumonia, n (%)10 (10.6%)12 (12.9%)0.80 (0.33–1.96)0.631
 AKI, n (%)1 (1.1%)2 (2.2%)0.49 (0.04–5.49)0.557
 Renal replacement therapy, n (%)1 (1.1%)1 (1.1%)0.99 (0.06–16.05)0.991
 Wound infection, n (%)1 (1.1%)1 (1.1%)0.99 (0.06–16.05)0.997
Safety outcomes
 Hypotension during infusion, n (%)2 (2.1%)2 (2.2%)1.69 (0.39–7.27)0.476
 Arrhythmias during infusion, n (%)4 (4.26%)3 (3.23%)1.20 (0.35–4.08)0.773
  1. Data are medians [Q1, Q3] for continuous variables and number of subjects (n) and percentage (%) for categorical variables. Differences between the percent values are given in percentage points, thus potentially not summing to the expected values as a consequence of rounding. Other variable differences are in the indicated units
  2. CI confidence interval, OR odds ratio, LCOS low cardiac output syndrome, AKI acute kidney injury