Table 2.
Outcomes | Hyperinsulinemic Normoglycemia (N = 709) | Standard Therapy (N = 730) | ||||
---|---|---|---|---|---|---|
N | Median (95% CI) | N | Median (95%CI) | HR (99.83%CI)* | P-value* | |
ICU stay (hrs) | 0.046b | |||||
649 | 25(24.9, 26.3) | 671 | 27 (25.2, 27.3) | 1.13 (0.95, 1.35) | 0.025 | |
Hospital stay (days)** | 0.07 b | |||||
686 | 8 [6, 12] | 713 | 8 [6, 12] | 1.05 (0.89, 1.25) | 0.35 | |
N | Event (%) | N | Event (%) | RR (99.83%CI)* | ||
Postoperative atrial fibrillation | 0.51 b | |||||
709 | 209 (29) | 730 | 235 (32) | 0.92 (0.75,1.13) | 0.29 | |
Any minor complicationa | 0.21 b | |||||
709 | 194(27) | 730 | 227(31) | 0.95 (0.87,1.04) | 0.13 | |
1-year mortality | 0.13 b | |||||
653 | 32 (5) | 682 | 22 (3) | 1.52 (0.74,3.11) | 0.12 |
Confidence intervals and P values from Cox proportional hazards for ICU stay and Hospital stay, and Cochran-Mantel-Haenszel test for binary outcomes. Confidence intervals adjusted for group sequential design using confidence coefficient of 2.633 for combined sites in order to maintain overall study alpha of 0.05. Significant if P < 0.0085 /6 = 0.0017 using Bonferroni correction.
The observed longest hospital stay + 1 day was assigned to patients who died during hospitalization (N = 22).
Minor complications include any one of the following: a prolonged requirement for mechanical ventilation (>72 hours), low cardiac index (cardiac index <1.8 l/min/m2 despite adequate fluid replacement and high dose inotropic support for >4 hours), acute kidney injury (increase in creatinine >100%), prolonged hospitalization (>30 days), and all-cause hospital readmission within 30 days).
treatment × site P-value.