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Table 1 Baseline characteristics of the two treatment groups

From: Inhaled nitric oxide as adjunctive therapy for severe malaria: a randomized controlled trial

 

iNO (N = 88)

Placebo (N = 92)

Female sex

35 (40 %)

43 (47 %)

Age (years), median (IQR)

2.0 (1.0–3.0)

2.0 (1.0–3.0)

Fever before enrolment (days), median (IQR)

3 (2–4)

3 (2–4)

Coma before enrolment (hours), median (IQR)

8.0 (3.0–11)

5.0 (2.0–15)

Pretreatment with anti-malarials

 None

36 (41 %)

42 (46 %)

 Ineffectivea

5 (6 %)

1 (1 %)

 Effectivea

47 (53 %)

49 (53 %)

Complications on admission

 Coma

54 (61 %)

52 (57 %)

 Convulsions

69 (78 %)

75 (82 %)

 Jaundice

13 (15 %)

15 (16 %)

 Severe anaemia (haemoglobin <50 g/L)

44 (50 %)

51 (55 %)

 Shock

9 (10 %)

12 (13 %)

 Hypotensive shock

1 (1 %)

1 (1 %)

 Severe acidosis (BE <−8 mmol/L)

36 (50 %)

33 (44 %)

 Hypoglycaemia (<3 mmol/L)

4 (5 %)

7 (8 %)

 Respiratory distressb

50 (57 %)

46 (50 %)

 Prostration

78 (89 %)

86 (93 %)

 Haemoglobinuria

18 (21 %)

16 (17 %)

 Hyperparasitaemia (>10 %)

10 (11 %)

7 (8 %)

Clinical examination

 Weight (kg), mean (SD)

11.5 (3.7)

11.7 (3.6)

 Temperature (°C), mean (SD)

38.0 (1.2)

37.9 (1.1)

 Blood pressure (mm Hg)

  

  Systolic, mean (SD)

108 (20)

113 (20)

  Diastolic, mean (SD)

58 (14)

60 (13)

  Blantyre coma score, median (IQR)

2 (2–3)

2 (2–3)

Co-morbidity

 HIV

4 (5 %)

1 (1 %)

 Suspected pneumoniac

8 (9 %)

12 (13 %)

 Clinical sepsisd

27 (31 %)

28 (30 %)

 Suspected meningitise

4 (5 %)

1 (1 %)

Laboratory assessments

 Parasitaemia (parasites per μL), geometric mean (range)f

15,700 (0–696,000)

19,300 (0–316,000)

 Sodium (mmol/L), mean (SD)

139 (5.0)

137 (4.6)

 Potassium (mmol/L), mean (SD)

4.2 (0.6)

4.1 (0.6)

 Chloride (mmol/L), mean (SD)

110 (6)

107 (5)

 Creatinine (umol/L), mean (SD)

44 (33)

36 (27)

 Haemoglobin (g/L), mean (SD)

61 (24)

62 (27)

 pH, mean (SD)

7.37 (0.12)

7.38 (0.11)

 PaCO2 (mm Hg), mean (SD)

28.0 (10.2)

28.1 (7.5)

 HCO3 (mmol/L), mean (SD)

10.0 (11.6)

10.7 (12.0)

 Plasma BE (mmol/L), mean (SD)

−2.8 (12.7)

−2.5 (12.2)

  1. Data are number (%), unless otherwise indicated
  2. SD standard deviation, IQR interquartile range, BE base excess, PaCO 2 partial pressure of carbon dioxide, HCO 3 bicarbonate
  3. aClassification of anti-malarial effectiveness followed AQUAMAT [25]. The following were considered effective: quinine injection, artemether injection, artesunate/artemether tabs, artemether-lumefantrine, artesunate suppository, artesunate-amodiaquine, artemether-amodiaquine, artemether-quinine, dihydroartemisinin (DHA), DHA-amodiaquine, and SP-artemether-lumefantrine. The following were considered intermediate or ineffective: sulfadoxine-pyrimethamine (SP), SP-amodiaquine, chloroquine, amodiaquine, and pyrimethamine-sulphamethopirazine
  4. bRespiratory distress was defined as nasal alar flaring, costal indrawing, or deep breathing
  5. cPneumonia was diagnosed on clinical grounds (chest radiographs were not performed routinely). Fast breathing and fever were signs used to make a diagnosis of pneumonia
  6. dBlood cultures were positive in 2/88 (2.3 %) iNO group and 8/91 (8·8 %) placebo: 6 coagulase-negative staphylococcus (likely contaminants); 2 Staphylococcus aureus; and 2 coliform Gram-negative organism. Of note, antibiotics had been given prior to venipuncture for blood culture in almost all cases
  7. eLumbar puncture was performed in 23/88 (26 %) iNO group and 28/92 (30 %) placebo. CSF culture was negative in all patients but one, which grew mixed Gram positive and Gram-negative organisms (likely contamination). The CSF leukocyte count was <5 cells/mm3 in all but one patient, who had 35 cells (predominantly lymphocytes) and negative blood culture
  8. fIn 10 cases, no parasites were seen on the admission blood smear, despite a positive screening RDT result. In one other case, the species was diagnosed as P. ovale. In all of these cases, PCR performed on the red blood cell pellet was positive for P. falciparum [24]