Table 1 Baseline characteristics for children in Phase II trial

Male, n (%)

15(58)

17(59)

0.94

Age, months (IQR)

15(14)

16(6)

0.41

Feature

N (%)

MUAC, mean ± SD

10.4(1.4)

10.0(1.9)

0.43

WHZ, mean ± SD

-3.4(1.3)

-3.9(1.0)

0.18

Severe wasting

14(54)

21(72)

0.15

Kwashiorkor

8(31)

4(14)

0.19

Desquamation

2(8)

1(3)

0.60

HIV positive*

9(35)

14(48)

0.65

Severity

N (%)

Deep breathing

18(69)

21(72)

0.88

Hypoxia (<95% or unrecordable)

3(12)

3(10)

0.57

Tachypnoea (>60 brpm)

16(62)

13(45)

0.22

Severe tachycardia (>160 bpm)

11(42)

8(28)

0.25

Capillary refill ≥3 s

15(58)

16(55)

0.53

Weak pulse volume

13(50)

19(66)

0.24

Bradycardia (<60 bpm)

0

0

Temperature gradient

17(65)

23(79)

0.25

Hypotension (SBP <70 mmHg)

5(19)

5(17)

0.44

WHO shock criteria

18(69)

23(79)

0.39

Hypothermia (ax. temp < 35°C)

0

0

Hydration

Reduced skin turgor

8(31)

16(55)

0.07

Sunken eyes

11(42)

19(66)

0.08

Consciousness

Coma

3(12)

4(14)

1.00

Prostration

15(58)

13(45)

0.34

Abnormal biochemistry N (%)

Acidosis (base deficit >8)

12(46)

20(69)

0.09

Creatinine (>80 μmols/L)

13(50)

13(49)

0.70

Hypokalaemia(<3.0 mmols/L)

16(62)

19(66)

0.76

Hyperkalaemia(>5.5 mmols/L)

2(7)

0

0.22

Hyponatraemia(<125 mmols/L)

4(15)

3(10)

0.58

Hypernatraemia (>145 mmols/L)

3(12)

3(10)

1.00

Hypoglycaemia(<3.0 mmols/L)

1(4)

4(14)

0.36

Hyperglycaemia(>10.0 mmols/L)

0

0

Mean laboratory variable, ± SD

Haemoglobin, g/dl

8.7(2.2)

8.9(1.9)

0.67

pH

7.25(0.25)

7.26(0.13)

0.79

Base deficit, mmol/L

14(11)

17(6)

0.26

Creatinine, μmol/L

107(78)

95(58)

0.53

Bicarbonate, mmol/L

14(13)

10(5)

0.16