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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]