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Table 1 Characteristics of the patients at randomisation

From: Valproic acid as adjuvant treatment for convulsive status epilepticus: a randomised clinical trial

Characteristics

n

Placebo (n = 118)

n

Valproic acid (n = 126)

Age, median (IQR) year

118

56.2 (44.7–68.1)

126

58.5 (44.8–68.6)

  > 65 year—no. (%)

118

41 (35)

126

44 (35)

Male sex—no. (%)

118

76 (64)

126

84 (67)

Medical history

History of epilepsy—no. (%)

117

57 (49)

123

60 (49)

Pre-existing anti-epileptic treatment—no. (%)

117

50 (43)

123

59 (48)

Other pre-existing neurological disease—no. (%)

117

64 (55)

123

71 (58)

Characteristics of the status epilepticus at randomisation

Acute brain injury—no. (%)

118

17 (14)

126

28 (22)

Seizure type—no. (%)

115

 

123

 

 Primary generalised status epilepticus

 

97 (84)

 

89 (72)

 Secondary generalised status epilepticus

 

18 (16)

 

34 (28)

Focal neurological signs—no. (%)

116

17 (15)

123

28 (23)

Time from seizure onset to ICU admission—median (IQR) h

109

2.5 (1.9–3.5)

116

2.7 (2.0–3.9)

First-line anti-epileptic drug—no. (%)

    

 Benzodiazepine§

117

109 (93)

124

115 (93)

Second-line anti-epileptic drugs– no. (%)

117

67 (57)

124

74 (60)

 Phenobarbital

117

13 (11)

124

28 (23)

 Levetiracetam

117

3 (3)

124

3 (2)

 Fosphenytoin/phenytoin

117

52 (44)

124

45 (36)

Sedation—no. (%)

117

40 (34)

124

44 (35)

 Midazolam

117

30 (26)

124

35 (28)

 Propofol

117

4 (3)

124

3 (2)

 Sodium thiopental

117

13 (11)

124

14 (11)

Interruption of seizure—no. (%)

117

102 (87)

123

107 (87)

Arousal before randomisation—no. (%)

117

10 (9)

124

13 (10)

Refractory status epilepticus—no. (%)

117

11 (9)

124

11 (9)

Mechanical ventilation—no. (%)

116

83 (72)

124

82 (66)

Glasgow coma scale—median (IQR)

112

4.0 (3.0–6.2)

117

3.0 (3.0–7.0)

SAPSII—median (IQR)

118

52 (42–61)

126

48 (38–59)

SOFA—median (IQR)

105

6.0 (5.0–8.0)

102

6.0 (4.0–7.0)

Final diagnosis—no. (%)*

118

 

126

 

 Acute symptomatic

 

41 (35)

 

46 (37)

 Remote symptomatic

 

31 (26)

 

35 (28)

 Progressive symptomatic

 

29 (25)

 

29 (23)

 Non-epileptic spell

 

2 (2)

 

0 (0)

 Other

 

2 (2)

 

2 (2)

 Unknown

 

13 (11)

 

14 (11)

  1. § All the patients who did not receive a first-line ASM were sedated by either propofol or midazolam, except five who received a second-line ASM. Therefore, all the patients met the inclusion criteria
  2. * Acute symptomatic generalised convulsive status epilepticus (GCSE) occurs at the time of a systemic insult or in close temporal association with a documented brain insult; remote symptomatic GCSE occurs some years after a significant brain injury; progressive symptomatic GCSE is related to progressive neurological disorders [1].
  3. IQR Interquartile range; SAPSII Simplified acute physiology score [36]; SOFA Sepsis-related Organ Failure Assessment Score [37]