Skip to main content

Table 4 Safety assessmenta

From: Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study

Outcomes ITT population TBI patients
  Saline
(N = 21)
Balanced
( N = 20)
P -value Saline
( N = 18)
Balanced
( N = 18)
P -value
Patients with an episode of ICH, n (%) 8 (38) 8 (40) 0.905 6 (33) 8 (44) 0.494
Number of ICH episode per patient, mean ± SD 3 ± 5 1 ± 2 0.912 3 ± 6 1 ± 1 0.957
Management of ICH, n (%)       
Osmotherapy (mannitol) 8 (38) 7 (35) 0.837 6 (33) 7 (39) 0.729
Barbiturate 7 (33) 6 (30) 0.819 5 (28) 6 (33) 0.718
Decompressive craniectomy 1 (5) 1 (5) 0.972 1 (6) 1 (6) 1
Therapeutic hypothermia 0 (0) 0 (0) 1 0 (0) 0 (0) 1
Modifications on CT, n (%)       
Bleeding 1 (5) 2 (10) 0.52 1 (6) 2 (11) 1
Herniation 0 (0) 1 (5) 0.3 0 (0) 1 (6) 1
Brain swelling 4 (19) 2 (10) 0.413 3 (17) 1 (6) 0.602
In ICU transfusion, n (%)       
Red blood cells 7 (33) 4 (20) 0.336 7 (39) 4 (22) 0.278
Fresh frozen plasma 5 (24) 1 (5) 0.089 5 (28) 1 (6) 0.178
Duration of norepinephrine infusion, days, median (IQR) 5 (2 to 7) 4 (2 to 7) 0.676 3 (1 to 4) 4 (2 to 6) 0.503
Potassium administration, n (%) 13 (60) 11 (55) 0.654 10 (56) 10 (56) 1
Calcium administration, n (%) 4 (20) 2 (10) 0.661 3 (17) 2 (11) 1
Azotaemia, (mol/L), median (IQR)       
Day 1 59 (56 to 68) 60 (50 to 67) 0.879 64 (57 to 74) 67 (59 to 71) 0.975
Day 2 60 (54 to 65) 56 (46 to 64) 0.289 58 (56 to 67) 62 (52 to 68) 0.734
Diuresis, L/day, median (IQR)       
Day 1 1.7 (1.2 to 2.5) 1.6 (1.1 to 2.1) 0.551 1.6 (1.2 to 2.3) 1.6 (1.2 to 2.0 0.756
Day 2 1.6 (1.0 to 2.6) 1.5 (1.0 to 2.0) 0.845 1.6 (1.0 to 2.2) 1.5 (1.0 to 2.0) 0.851
Time to achieve >50% of goal calories of enteral nutrition, days, median (IQR) 4 (3 to 5) 3 (3 to 11) 0.911 4 (3 to 6) 3 (3 to 11) 1
Duration of mechanical ventilation, days, median (IQR) 12 (5 to 18) 12 (8 to 19) 0.823 10 (2 to 18) 10 (7 to 19) 0.76
ICU length of stay, days, median (IQR) 19 (10 to 24) 16 (8 to 21) 0.521 18 (10 to 24) 14 (7 to 21) 0.591
Death in ICU, n (%) 3 (14) 5 (25) 0.387 2 (11) 5 (28) 0.402
Refractory ICH 2 (10) 2 (10)   1 (6) 2 (11)  
Care withdrawal 1 (5) 3 (15)   1 (6) 3 (17)  
  1. aCT: computed tomography, ICH: intracranial hypertension, IQR: interquartile range, ITT: intention to treat; TBI: traumatic brain injury.