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

Malaria Journal

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

	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 malaria^a	7/81 (8.6 %)	9/88 (10 %)	0.83 (0.29–2.3)	0.73
Mortality in strictly defined cerebral malaria^b	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 coma^c	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 admission^c	11/35 (31 %)	5/34 (15 %)	2·7 (0.81–8.7)	0.10
Haemoglobinuria^c	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

OR odds ratio
^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)
^bStrictly defined cerebral malaria required Blantyre coma scale <3, exclusion of hypoglycaemia and post-ictal state as the cause of coma
^cDevelopment of coma, anaemia and haemoglobinuria was assessed only in patients without these disorders on admission

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