Variable | Dantrolene (n=16) | Placebo (n=15)† | p Value* |
---|---|---|---|
Age (Mean±SD) | 56±12 | 52±11 | |
Female gender (N, %) | 14 (87.5) | 12 (80.0) | |
Race/ethnicity (N, %) | 0.01 | ||
White | 15 (95.8) | 9 (60.0) | |
Hispanic | 0 | 6 (40.0) | |
AA | 1 (6.3) | 0 | |
Hunt & Hess Scale (Median, IQR) | 2 (1.5;3) | 3 (2;4) | |
1 | 4 | 2 | |
2 | 6 | 4 | |
3 | 4 | 5 | |
4 | 1 | 2 | |
5 | 1 | 2 | |
Fisher Scale (Median, IQR) | 3 (2.5;3) | 3 (3;3) | |
1 | 1 | 1 | |
2 | 3 | 1 | |
3 | 11 | 13 | |
4 | 1 | 0 | |
Modified Fisher Scale (Median, IQR) | 4 (3;4) | 3 (3;4) | |
1 | 2 | 1 | |
2 | 0 | 2 | |
3 | 5 | 7 | |
4 | 9 | 5 | |
Aneurysm secured (median days, IQR after SAH) | 1 (0;2) | 0 (0;1) | |
Coiled (N, %) | 16 (100.0) | 12 (80.0) | |
Clipped (N, %) | 0 | 3 (20) | |
Intubated | 4 (25.0) | 5 (33.0) | |
Nimodipine (N, %) | 16 (100.0) | 15 (100.0) | |
Weight (Mean±SD) | 84.0±32.4 | 79.1±17.6 | |
First dose dantrolene (median days, IQR after SAH) | 3 (2;4) | 3 (2;4) | |
Baseline laboratory values (Mean±SD) | |||
sNa | 139.3±3.1 | 140.6±3.5 | |
ALT | 21.9±9.3 | 25.5±15.2 | |
AST | 24.5±10.0 | 31.2±13.5 | |
AlkPhos | 60.9±11.0 | 61.7±20.3 | |
Cumulative medication doses over 7-day study period (Mean±SD) | |||
Acetaminophen (mg) | 2986±4538 | 8263±8291 | 0.035 |
Phenytoin/fosphenytoin (mg) | 756±1006 | 1073±1055 | |
Simvastatin (mg) | 399±178 | 387±184 | |
Fludrocortisone 0.4 mg twice daily (N, %) | 6 (37.5) | 8 (53.3) | |
Hypertonic saline (meQ Na) | 336±399 | 421±483 |
*None of the p values (unless listed) reached statistical significance (<0.05).
†Baseline characteristics are listed for all enrolled patients, including two placebo patients, which withdrew consent during placebo infusion for all subsequent time points. Clinical and radiological severity scales were determined by consensus by the treating neurointensivist and vascular neurosurgeon.
SAH, subarachnoid haemorrhage.