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Table 2 Mortality, complications and co-treatments according to treatment group

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

  iNO (n/N, %) Placebo (n/N, %) OR (95 % CI) p value
Mortality
 Mortality, 48 h 6/87 (6.9 %) 8/92 (8.7 %) 0.78 (0.26–2.3) 0.65
 Mortality, in hospital 7/87 (8.0 %) 8/92 (8.7 %) 0.92 (0.32–2.7) 0.88
 Mortality, 14 days 7/87 (8.0 %) 9/91 (9.9 %) 0.80 (0.28–2.2) 0.67
 Death or sequelae at 14 days 12/87 (13 %) 16/91 (14 %) 0.75 (0.33–1.7) 0.75
 Mortality in strictly defined severe malariaa 7/81 (8.6 %) 9/88 (10 %) 0.83 (0.29–2.3) 0.73
 Mortality in strictly defined cerebral malariab 6/53 (11 %) 8/51 (16 %) 0.69 (0.22–2.1) 0.51
 Mortality in HIV 1/4 (25 %) 0/1 (0 %) 1.0
Complications
 Development of comac 2/26 (7·7 %) 0/34 (0 %) 0.18
 Deterioration of coma score 8/86 (9·3 %) 5/91 (5·5 %) 1·8 (0·55–5·6) 0.33
 Convulsions developing or persisting >6 h after admission 19/87 (22 %) 13/91 (14 %) 1.7 (0·77–3·6) 0.19
 Hypoglycaemia (<3 mmol/L) 10/88 (10 %) 17/91 (19 %) 0.56 (0·24–1·3) 0.12
 Severe anaemia (<50 g/L) after admissionc 11/35 (31 %) 5/34 (15 %) 2·7 (0.81–8.7) 0.10
 Haemoglobinuriac 0/68 (0 %) 3/76 (3.9 %) 0 (0–3.6) 0.25
Co-treatments
 Blood transfusion 65/87 (75 %) 67/91 (74 %) 1.1 (0.54–2.1) 1.0
 Intravenous fluids 80/88 (91 %) 82/91 (90 %) 1.1 (0.40–3.0) 1.0
 Antibiotics (any) 82/87 (94 %) 80/91 (88 %) 2.3 (0.75–6.8) 0.19
 Ceftriaxone 81/87 (93 %) 76/91 (84 %) 2.7 (0.98–7.2) 0.06
 Anticonvulsant (any) 51/87 (59 %) 36/91 (40 %) 2.2 (1.2–3.9) 0.016
 Diazepam 40/87 (46 %) 27/91 (30 %) 2.0 (1.1–3.7) 0.030
 Phenobarbitone 29/87 (33 %) 23/91 (25 %) 1.5 (0.77–2.8) 0.25
 Antipyretic (any) 64/87 (74 %) 71/91 (78 %) 0.78 (0.39–1.6) 0.60
  1. OR odds ratio
  2. aStrictly defined severe malaria as in AQUAMAT [25]. At least one of the following criteria was required: plasma base excess <–3.3 mmol/L; Blantyre coma scale <3/5; haemoglobin <50 g/L and parasitaemia >100,000 parasites/μL; compensated shock (capillary refill ≥3 s but no hypotension); decompensated shock (systolic blood pressure <70 mmHg and cool peripheries); asexual parasitaemia >10 %; visible jaundice and >100,000 parasites/μL; plasma glucose <3 mmol/L; respiratory distress (defined as costal indrawing, use of accessory muscles, nasal alar flaring, or deep breathing)
  3. bStrictly defined cerebral malaria required Blantyre coma scale <3, exclusion of hypoglycaemia and post-ictal state as the cause of coma
  4. cDevelopment of coma, anaemia and haemoglobinuria was assessed only in patients without these disorders on admission