Table 2 Reasons for protocol non-adherence
Variables | All (N = 83) | CG (N = 43) | Ketamine (N = 40) |
|---|---|---|---|
None | 63 (76) | 32 (74.4) | 31 (77.5) |
Violated inclusion criteria | 1 (1.2) | 0 (0) | 1 (2.5) |
Violated exclusion criteria | 1 (1.2) | 1 (2.3) | 0 (0) |
Missed or discontinued trial protocol, N (%) | 18 (21.7) | 10 (23.3) | 8 (20) |
Reasonsa | |||
 Excessive sedation and patients not in target RASS, N (%) | 2 (2.4) | 0 (0) | 2 (5) |
 Death at 48 h post-randomization, N (%) | 4 (4.8) | 2 (4.7) | 2 (5) |
 Goal of care changed to comfort care, N (%) | 2 (2.4) | 1 (2.3) | 1 (2.5) |
 Physician decline patient participation post-randomization, N (%) | 1 (1.2) | 0 (0) | 1 (2.5) |
 Persistent tachycardia within the first 48 h [HR > 150 beats/min], N (%) | 4 (4.8) | 1 (2.3) | 3 (7.5) |
 Persistent hypertension within the first 48 h [systolic blood pressure ≥ 180 mmHg], N (%) | 1 (1.2) | 0 (0) | 1 (2.5) |
 New structural brain disease, N (%) | 4 (4.8) | 4 (9.3) | 0 (0) |
  Unknown reason, N (%) | 2 (2.4) | 2 (4.7) | 0 (0) |