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Table 1 Baseline information for the clinical trial population

From: Assessing the efficacy and safety of magnesium sulfate for management of autonomic nervous system dysregulation in Vietnamese children with severe hand foot and mouth disease

 

Placebo (N = 12)

MgSO4 (N = 14)

Demographic and clinical features

 Age (months)

21 (7, 57)

24 (9, 73)

 Sex (female)

6 (50)

9 (64)

 Weight (kg)

11 (7, 19)

11 (7, 20)

 Illness day at enrolment

3.5 (1.0, 6.0)

3.0 (2.0, 5.0)

 Fever (>  37.5 °C)

12 (100)

13 (93)

 Mouth ulcers present

10 (83)

11 (79)

 Skin lesions present

9 (75)

11 (79)

 Skin ANS featuresa

2 (17)

1 (7)

 Tachycardiab

2 (17)

1 (7)

 SBP (mmHg)

116 (105, 129)

113 (101, 134)

 DBP (mmHg)

61 (52, 73)

59 (47, 73)

 Stage of hypertension

  Stage1

4 (33)

11 (79)

  Stage2

8 (67)

3 (21)

 Tachypnea

5 (42)

6 (43)

 Irregular breathing

7 (58)

5 (36)

 Respiratory retractions

1 (8)

3 (21)

 Irritability

4 (33)

1 (7)

 Neurological abnormalitiesc

3 (25)

0 (0)

Laboratory investigations

 Arterial blood gases

  - pH

7.44 (7.40, 7.59)

7.41 (7.36, 7.48)

  - pCO2 (mmHg)

29.8 (18.6, 35.7)

33.3 (29.4, 40.1)

 Hb (g/dl)

11.8 (8.8, 15.2)

11.8 (6.4, 14.3)

 WBC (× 109/l)

10.2 (4.6, 15.5)

13.6 (5.5, 26.5)

 CK-MB (IU/l)

23.4 (10.4, 64.8)

25.4 (13.8, 48.1)

 Troponin I (pg/ml)

5 (0, 20)

5 (0, 27)

 Mg (mmol/l)

0.85 (0.70, 0.99)

0.88 (0.78, 0.98)

 Ca (mmol/l)

2.28 (1.69, 2.52)

2.31 (1.95, 2.42)

 Na (mmol/l)

131 (126, 134)

131 (125, 136)

 Creatinine (μmol/l)

26 (17, 52)

27 (18, 42)

 Blood sugar (mmol/l)

5.4 (4.0, 7.6)

5.7 (5.0, 8.1)

 Lab-confirmed EV infection

7 (58)

11 (78)

  EV-A71 positive

4 (33)

9 (64)

  Other EV positived

3 (25)

2 (14)

  1. Summary statistic is absolute count (%) for categorical variables and median (range) for continuous data
  2. SBP Systolic blood pressure, DBP Diastolic blood pressure, EV-A71 Enterovirus A71, EV Enterovirus
  3. aSkin manifestations of autonomic nervous system (ANS) dysregulation
  4. bTachycardia: Heart rate sustained > 150 beats/min, adjusted down by 10 for each 1 degree of fever above 37.0
  5. cMyoclonic jerks were noted in 2 cases, while limb tremor/ataxia and nystagmus were present in 1 case, all in the placebo group
  6. dIncludes 3 cases of Coxsackievirus (CV) A16, 1 case of CV A10, 1 case of CV –C, all other cases were negative