Table 3.
Main results on non-outcome variables.
| ITT analyses, first 72 hours post-ROSC |
Exploratory ITT analyses, 10-day follow-up |
Additional presentation a | |||||
|---|---|---|---|---|---|---|---|
| Hemodynamic support and related variables b | Control group | Steroids group | P-value | Control group | Steroids group | P-value | Figures S11–S18 |
| Vasopressor infusion rate EMM (95% CI), μg/kg/min c | 0.30 (0.16–0.55) | 0.31 (0.18–0.52) | 0.89 | 0.18 (0.11–0.29) | 0.16 (0.10–0.27) | 0.78 | Figure 2B |
| Fluid balance, EMM (95% CI), mL | 927 (–93 to 1948) | 2125 (1306–2944) | 0.01 | 1071 (408–1735) | 1652 (1048–2257) | 0.07 | Figure S11 |
| Arterial blood lactate, EMM (95% CI), mmol/L | 4.5 (1.7–7.3) | 6.2 (3.8–8.6) | 0.20 | 2.9 (0.4–5.4) | 5.7 (3.5–7.9) | 0.03 | Figure S12 |
| Arterial blood pH, EMM (95% CI) | 7.36 (7.32–7.41) | 7.31 (7.27–7.35) | 0.004 | 7.35 (7.30–7.40) | 7.34 (7.28–7.39) | 0.69 | Figure S18 |
| ITT analysis, at 12 hours post-ROSC |
ITT analysis, at 72 hours post- ROSC |
||||||
| Control group | Steroids group | P-value | Control group | Steroids group | P-value | ||
| Cerebral autoregulation (by NIRS) adequate, d no./total no. (%) e | 5/14 (35.7) | 6/15 (40.0) | >0.99 | 6/14 (42.9) | 4/11 (36.4) | >0.99 | Table S4 |
| ITT analysis, 60-day follow-up |
|||||||
| Control group | Steroids group | P-value | |||||
| Shock reversal in patients with PRS, no./total no. (%) f | 16/49 (32.7) | 16/43 (37.2) | 0.68 | NA | |||
| Days to first cessation of vasopressors, median (IQR); max g | 2.0 (1.3-4.8); 9.0 | 3.5 (3.0-6.0); 8.0 | 0.18 | NA | |||
| Exploratory analysis, first 72 hours post-ROSC |
Additional presentation a | ||||||
| Control group | Steroids group | P-value | Supplemental Results and Figure S19 | ||||
| Mean systemic filling pressure, EMM (95% CI),mmHg h | 20.2 (18.9–21.6) | 20.0 (18.1–22.0) | 0.86 | ||||
| Cardiac pump performance, EMM (95% CI), fraction of unity h | 0.51 (0.47–0.55) | 0.46 (0.42–0.50) | 0.10 | ||||
| Systemic vascular resistance, EMM (95% CI), dynes * s/cm5h | 1131 (1012–1248) | 1113 (993–1232) | 0.83 | ||||
| Control group | Steroids group | P-value | |||||
| Ventilator free days, median (IQR), max. i | 0.0 (0.0-2.0), 58.0 | 0.0 (0.0-5.0), 53.0 | 0.77 | NA | |||
| Length of hospital stay, days – median (IQR); max. | 7.5 (0.9-32.5); 218.0 | 4.5 (0.7-41.3); 147.0 | 0.25 | Table S8j | |||
ITT, intention to treat; ROSC, return of spontaneous circulation, EMM, estimated marginal mean (by linear mixed-model analyses; see also.
Statistical Analysis); CI, confidence interval; NIRS, near-infrared spectroscopy; BS, broad spectrum; PRS, postresuscitation shock. NA, not applicable. P-values corresponding to ≥2 consecutive comparisons were subjected to the Bonferroni correction.
This column cites mainly supplemental Figures and Tables with detailed reporting of the results of the ITT analyses.
Ranges of % missing follow-up datapoints through day 10 post-ROSC for the presented variables: control group, 2.2–13.4%; steroids group, 3.0–13.8%; see Supplement for further details.
Calculated as the sum of the infusion rates of norepinephrine (in μg/kg/min), dopamine/2 (in μg/kg/min), and epinephrine (in μg/kg/min).40
Cerebral autoregulation was defined as adequate according to the following criterion: Pearson correlation coefficient between mean arterial pressure and prefrontal cortex tissue oxygenation index of <0.3;34 see Methods and Supplemental Methods for further details.
No. of patients with available data, ITT analysis at 12 hours post-ROSC, control group, 14; steroids group, 15; ITT analysis at 72 hours post-ROSC, control group, 14; steroids group, 11.
Defined as maintenance of a mean arterial pressure of >70 mmHg without any vasopressor support for a minimum of 24 hours.
Variable pertains solely to patients who had PRS followed by shock reversal.
Formulas of determination are presented in the Supplement; data originate from all patients who received cardiac output monitoring. (control group, 32; steroids group, 27); a cardiac pump performance of 1.00 is considered to reflect normal heart function.39
No. of patients with available data, ITT analysis, control group, 54; steroids group, 46.
Supplemental Table S8 displays additional details on the length of intensive/coronary care unit stay.