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Table 3 Clinical outcomes

From: Adjunctive ketamine for sedation in critically ill mechanically ventilated patients: an active-controlled, pilot, feasibility clinical trial

Variables All (N = 83) CG (N = 43) Ketamine (N = 40) p
Clinical outcomes
 Liberation from MV within 28 days post-intubation, N (%) 52 (62.7) 27 (62.8) 25 (62.5) 1
 28-day duration of MV, days 5 (2–9) 5 (2–8) 7 (3–9.25) 0.15
 Duration of MV at ICU discharge/death, days 8 (3–18.5) 7 (3–13.8) 9 (3–19) 0.32
 Ventilation-free days, daysa 19 (0–24) 19 (0–24) 19 (0–24.75) 0.70
 Patients at goal RASS at 24 h, N (%)b 49 (59.8) 22 (52.4) 27 (67.5) 0.24
 Patients at goal RASS at 48 h, N (%)c 51 (69.9) 26 (66.7) 25 (73.5) 0.70
 Patients at goal pain score at 24 h, N (%)d 80 (96.39) 41 (95.35) 39 (97.5) 1
 Patients at goal pain score at 48 h, N (%)d 79 (95.2) 41 (95.3) 38 (95) 1
 Discharge from ICU, N (%) 76 (91.6) 40 (93) 36 (90) 0.71
 ICU length-of-stay, days 12 (6–22.5) 12 (5.5–23) 12.5 (6–21.2) 0.89
 Hospital discharge, N (%) 79 (95.2) 41 (95.3) 38 (95) 1
 Hospital length-of-stay, days 26 (13–39) 27 (12.5–47) 26 (15.8–38) 0.87
Safety outcomes
 CAM-ICU positive, N (%)e 2 (2.41) 0 (0) 2 (5) 0.30
 Patients who did not complete 48 h of trial, N (%) 20 (24.1) 5 (11.63) 15 (37.5) 0.01
 Hemodynamics
  HR at 24 h 92 (75.5–107) 95 (80–107) 83.5 (71.8–105) 0.11
  HR at 48 h 84 (72–100) 89 (75–104) 82 (71–99) 0.31
  MAP at 24 h 75 (64.5–87) 75 (62.5–86.5) 74.5 (69.5–91.5) 0.31
  MAP at 48 h 77 (65–90) 76 (67.5–87) 77.5 (64–92.5) 0.50
 Uncontrolled agitation, N (%) 10 (12.05) 4 (9.3) 6 (15) 0.51
 Combative behavior to the nursing staff, N (%) 2 (2.41) 1 (2.33) 1 (2.5) 1
 Hyper-salivation and frequent suctioning, N (%) 22 (26.5) 14 (32.6) 8 (20) 0.29
 Antipsychotics within 48 h post-randomization, N (%) 7 (8.43) 4 (9.3) 3 (7.5) 1
 Use of physical restraint 48 h post-randomization, N (%) 22 (26.5) 10 (23.3) 12 (30) 0.66
 28-day mortality rate, N (%) 25 (30.1) 14 (32.6) 11 (27.5) 0.79
  1. Data presented as n (%), mean ± sd, or median (interquartile range)
  2. CAM-ICU Confusion Assessment Method for the ICU, CG control group (donates to standard of care), HR heart rate, MV mechanical ventilation, MAP mean arterial pressure, RASS Richmond Agitation and Sedation Scale
  3. aVFDs were calculated by subtracting number of ventilation days from 28 after assigning VFD = 0 for patients who died during 28 days
  4. bThe RASS measures levels of consciousness (scores range from − 5 [unresponsive] to + 4 [combative]). Assessed in 82 patients at 24 h (42 CG and 40 ketamine)
  5. cThe RASS was assessed in 73 patients at 48 h (39 CG and 34 in ketamine)
  6. dAssessment of pain was done by Critical Care Pain Observation Tool for pain (CPOT)
  7. eThe CAM-ICU, scores delirium as either present [positive] or not present [negative]. Assessments were done when the patient was maximally awake. If in coma, unable to evaluate