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) |