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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.
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