Table 10.3.
Results of secondary endpoints: mod-PPS population.
| Secondary endpoint | Statistic s | Cardioplexol™ (n = 111) | Buckberg (n = 126) | Comparison | |
|---|---|---|---|---|---|
| 1 | Maximal value of CK-MB during the first 24 h (U/L) | meana 95% CIa | 52.7 (47.8–58.1) | 54.2 (49.4–59.4) | 0.97 (0.85–1.11) p = 0.684 |
| 2 | Time between aortic crossclamping and the complete cardiac arrest (sec) | Median range | 12 (2–261) | 71 (13–551) | p < 0.0001c |
| 3 | Catecholamines during aortic cross-clamping | Yes | 110 (99%) | 125 (99%) | p > 0.9d |
| 4 | Cumulative dose of catecholamines during aortic cross-clamping | Median range | 779 (30–9,270) | 791 (6–24,877) | p = 0.218c |
| 5 | Defibrillation after aorta unclamping and coronary reperfusion | Yes | 13 (12%) | 65 (52%) | p < 0.0001d |
| 6 | Cumulative dose of catecholamines during the first 24 h | Median range | 6,000 (178–70,800) | 7,170 (329–131,394) | p = 0.030c |
| 7 | Installation of an IABP in the first 24 h | Yes | 0 | 5 | p = 0.062d |
| 8 | Duration of intubation (h) | Median range | 13.0 (4.5–102) | 13.5 (7–480) | p = 0.094c |
| 9 | Duration of ICU stay (h) | Median range | 37.8 (12.2–173.3) | 44.0 (14.8–503.9) | p = 0.147c |
| 10 | Death during the first 24 h | Yes | 0 | 1 | p > 0.9d |
| 11 | Maximal ST elevation during the first 24 h (mm) | Median range | 2.0 (0–5) | 2.0 (0–5) | p > 0.9c |
| 12 | Duration of hospitalization (days) | Median range | 10 (7–28) | 11 (2–30) | p = 0.105c |
a
Geometric mean and CI based on back transformed (anti-log) CK-MB values.
b
Ratio of geometric means and corresponding 95% CI based on back transformed values.
c
Ttest for two independent groups.
d
Fisher's exact test.