Table 2.
Summary results on study outcomes (besides functional in-hospital outcome, which is presented in Fig. 3).
| ITT analyses, first 72 hours post-ROSC |
Exploratory ITT analyses, 10-day follow-up |
Additional presentation a | |||||
|---|---|---|---|---|---|---|---|
| Primary outcomes b | Control group | Steroids group | P-value | Control group | Steroids group | P-value | |
| Systolic arterial pressure, EMM (95% CI), mmHg | 109 (100–120) | 111 (102–120) | 0.64 | 119 (110–128) | 118 (110–127) | 0.97 | Figure S1 |
| Diastolic arterial pressure, EMM (95% CI), mmHg | 54 (49–60) | 55 (50–60) | 0.71 | 55 (51–61) | 54 (50–59) | 0.44 | Figure S2 |
| Mean arterial pressure, EMM (95% CI), mmHg | 72 (66–79) | 74 (68–80) | 0.61 | 77 (71–83) | 75 (70–81) | 0.78 | Figure 2A |
| Central venous oxygen saturation, EMM (95% CI), (%) | 69 (65–73) | 71 (68–75) | 0.17 | 70 (65–74) | 72 (68–77) | 0.18 | Figure S3 |
| Secondary outcomes | Control group | Steroids group | P-value | Control group | Steroids group | P-value | |
| Cardiac index, EMM (95% CI), L/min/m2 BSA c | 2.9 (2.5–3.2) | 2.8 (2.5–3.1) | 0.79 | 2.9 (2.5–3.2) | 3.1 (2.7–3.5) | 0.33 | Figure S4 |
| ITT analyses, at 12 hours post-ROSC | ITT analyses, at 72 hours post-ROSC | ||||||
| Echocardiographic variables d | Control group | Steroids group | P-value | Control group | Steroids group | P-value | |
| LVEDA, median (IQR) at 12 hours, mean (SD) at 72 hours, cm2 | 19.4 (15.9–29.2) | 24.0 (17.8–30.6) | >0.99 | 18.5 (2.9) | 23.6 (7.9) | 0.051 e | Table S3 |
| RVEDA, mean (SD), cm2 | 13.0 (4.0) | 12,1 (4.2) | 0.98 | 12.6 (4.1) | 14.3 (3.7) | 0.48 | Table S3 |
| LVEF, median (IQR), (%) | 50.0 (37.5–50.0) | 45.0 (30.0–55.0) | 0.62 | 55.0 (45.0–55.0) | 45.0 (32.5–55.0) | 0.44 | Table S3 |
| RVEF, mean (SD), (%) | 42.7 (9.3) | 41.3 (8.7) | >0.99 | 44.7 (7.1) | 42.2 (8.4) | 0.94 | Table S3 |
| Secondary outcomes |
ITT analyses, within 4-12 hours of ROSC f |
ITT analyses, at 72 hours post- ROSC |
Additional presentationa | ||||
| NIRS-derived variablesg | Control group | Steroids group | P-value | Control group | Steroids group | P-value | |
| Prefrontal cortex BFI, median (IQR), nM/s, 1st Measurement | 2.8 (1.7–4.1) | 3.3 (2.4–4.5) | 0.60 | 2.4 (1.8–5.4) | 3.7 (1.5–6.4) | >0.99 | Table S4 |
| Prefrontal cortex BFI, median (IQR), nM/s, 2nd Measurement | 3.9 (1.6–4.9) | 3.3 (2.8–4.9) | >0.99 | 3.9 (1.8–4.9) | 3.3 (1.6–7.2) | >0.99 | Table S4 |
| ITT analyses, over 48 hours of ROSC |
|||||||
| Control group | Steroids group | P-value | |||||
| Core body temperature, mean (SD), degrees Celsius h | 36.4 (1.1) | 36.2 (1.1) | 0.03 | Table S5 | |||
| ITT analyses, first 72 hours post-ROSC |
Exploratory ITT analyses, 7-day follow-up |
||||||
| Serum cytokine concentrations i | Control group | Steroids group | P-value | Control group | Steroids group | P-value | |
| Tumor necrosis factor alpha, EMM (95% CI), pg/mL | 83.1 (46.1–149.9) | 91.4 (53.0–157.8) | 0.70 | 82.3 (45.5–148.9) | 90.4 (52.2–156.5) | 0.70 | Figure S5 |
| Interleukin 1-beta, EMM (95% CI), pg/mL | 99.5 (84.9–116.7) | 109.5 (94.0–127.4) | 0.12 | 99.8 (45.5–148.9) | 110.5 (52.2–156.3) | 0.12 | Figure S6 |
| Interleukin 6, EMM (95% CI), pg/mL | 75.7 (42.8–133.9) | 89.1 (52.1–152.3) | 0.48 | 78.3 (44.7–137.2) | 81.6 (48.1–138.4) | 0.86 | Figure 2C |
| Interleukin 8, EMM (95% CI), pg/mL | 146.7 (90.6–237.3) | 138.3 (87.5–218.5) | 0.75 | 143.9 (89.0–232.6) | 129.5 (82.0–204.6) | 0.58 | Figure S7 |
| Interleukin 10, EMM (95% CI), pg/mL | 22.8 (11.9–43.6) | 31.5 (17.2–57.8) | 0.22 | 21.6 (11.3–41.0) | 28.8 (15.8–52.7) | 0.27 | Figure S8 |
| Secondary outcomes | ITT analyses, 60-day follow-up |
Additional presentation a | |||||
| Organ failure free days j | Control group | Steroids group | P-value | NA | |||
| Circulatory failure free days, median (IQR), max. | 0.0 (0.0–12.8), 59.0 | 0.0 (0.0–26.8), 60.0 | 0.84 | ||||
| Neurologic failure free days, median (IQR), max. | 0.0 (0.0–0.0), 59.0 | 0.0 (0.0–1.0), 56.0 | 0.33 | ||||
| Renal failure free days, median (IQR), max. | 1.0 (0.0–13.0), 60.0 | 1.0 (0.0–44.0), 60.0 | 0.97 | ||||
| Respiratory failure free days, median (IQR), max. | 3.0 (0.0–31.8), 60.0 | 3.0 (0.0–46.8), 60.0 | 0.83 | ||||
| Coagulation failure free days, median (IQR), max. | 7.0 (0.0–29.8), 60.0 | 3.5 (0.0–48.3), 60.0 | 0.79 | ||||
| Hepatic failure free days, median (IQR), max. | 7.0 (0.0–31.0), 60.0 | 5.0 (0.5–52.5), 60.0 | 0.92 | ||||
| ITT analyses, follow-up until hospital discharge |
|||||||
| Adverse events potentially associated with steroids k | Control group | Steroids group | P-value | Table S7 | |||
| Sepsis /septic shock, no./total no. (%) | 17/54 (31.5) | 16/46 (34.8) | 0.83 | ||||
| Hospital-acquired pneumonia, no./total no. (%) | 7/54 (13.0) | 11/46 (23.9) | 0.20 | ||||
| Urinary tract infection, no/total no. (%) | 3/54 (5.6) | 0/46 (0.0) | 0.25 | ||||
| Paresis, no./total no. (%) | 4/54 (7.4) | 4/46 (8.7) | >0.99 | ||||
| Upper gastrointestinal bleeding– no./total no. (%) | 1/54 (1.9%) | 0/46 (0.0) | >0.99 | ||||
| Episodes of hyperglycemia/patient-day, median (IQR), max. | 0 (0–2), 9 | 0 (0–2), 7 | 0.63 | ||||
| Episodes of hypernatremia/patient-day, median (IQR), max. | 0 (0–0), 2 | 0 (0–0), 3 | 0.68 | ||||
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; BSA, body surface area; LVEDA and RVEDA, left and right ventricular end-diastolic area, respectively; LVEF and RVEF, left and right ventricular ejection fraction, respectively; NIRS, near-infrared spectroscopy; 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, 0.5–25.6%; steroids group, 1.8–24.7%.
% missing follow-up datapoints through day 10 post-ROSC: control group, 20.0%; steroids group, 28.6%.
Ranges of number of patients with available data for the presented variables: at 12 hours post-ROSC, control group, 16–29; steroids group, 20–28; at 72 hours post-ROSC, control group, 9–15; steroids group, 13–17.
The uncorrected P value of 0.025 was statistically significant.
Following ICU admission, day-1 data on prefrontal cortex BFI were actually collected at a median (IQR) of 5.5 (3.8–12.0) and 8.8 (4.0–12.0) hours post-ROSC in steroids and control group, respectively (P = 0.35).
Number of patients with available data: at 12 hours post-ROSC, control group, 14; steroids group, 15; at 72 hours post-ROSC, control group, 14; steroids group, 11; at 72 hours post-ROSC, mean PaCO2 was approximately 5 mmHg lower in steroids group vs. control (P = 0.005).
Number of patients with available data: ITT analysis, control group, 42; steroids group, 38.
Ranges of % missing follow-up datapoints through day 10 post-ROSC for the presented variables: control group, 14.1–14.1%; steroids group, 20.2–20.7%.
Number of patients with available data: ITT analyses, all variables (besides hepatic failure free days), control group, 54; steroids group, 46; ITT analysis, hepatic failure free days, control group, 51; steroids group, 45.
Number of patients with available data: ITT analyses (all variables), control group, 54; steroids group, 46.