Background
Methods
Study design, study population and sampling
Definitions of model outcomes and candidate predictors
Definitions of parameters
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Uraemia: Blood Urea Nitrogen > 20 mg/dl.
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Severe anaemia: Hb < 5 g/dl.
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Mild anaemia: Hb > 5, < 10 g/dl.
Statistical analysis
Ethical considerations
Results
Variable | N (%) | Artesunate N (%) | Quinine N (%) |
---|---|---|---|
Sample size: 5425 | |||
Patient demographics | |||
Congo | 422 (7.8) | 212 (50.2) | 210 (49.8) |
Gambia | 502 (9.3) | 250 (49.8) | 252 (50.2) |
Ghana | 436 (8) | 218 (50) | 218 (50) |
Kenya | 442 (8.3) | 219 (49.6) | 223 (50.5) |
Mozambique | 664 (12.2) | 332 (50) | 332 (50) |
Nigeria | 450 (8.3) | 226 (50.2) | 224 (49.8) |
Rwanda | 386 (7.1) | 194 (50.3) | 192 (49.7) |
Tanzania | 1461 (26.9) | 729 (49.9) | 732 (50.1) |
Uganda | 663 (12.2) | 333 (50.2) | 330 (49.8) |
Age (Median, IQR: 25–75) | 2 (1- 4) | 2 (1–4) | 2 (1−4) |
Females | 2611 (48.1) | 1298 (47.7) | 1316 (48.5) |
Male | 2815 (51.9) | 1418 (52.3) | 1397 (51.5) |
Clinical characteristics | |||
Coma at admission (BCS < = 2) | 1823 (33.6) | 881 (48.3) | 942 (51.7) |
Severe prostration (Not able to breast feed < 6 m or able to sit > 6 m) | 2974 (54.8) | 1505 (50.6) | 1469 (49.3) |
Convulsions (> 30 min) | 1355 (31.2) | 637 (47) | 718 (52.9) |
Decompensated shock (BP < 70mmhg) | 178 (3.3) | 88 (49.4) | 90 (50.6) |
Deep breathing | 938 (17.3) | 495 (52.8) | 443(47.2) |
Respiratory distress (costal in drawing/ recession / respiratory insufficiency | 867 (15.9) | 439 (50.6) | 428 (49.4) |
Symptomatic severe anaemia (severe pallor combined with respiratory distress) | 2213 (40.8) | 1131 (51.1) | 1082 (48.9) |
Black water fever (haemoglobinuria) | 237 (4.4) | 121 (51.1) | 116 (48.9) |
Severe jaundice | 114 (2.1) | 55 (48.3) | 59 (51.8) |
Anuria / Oliguria (in adults and children—History) | 7 (0.1) | 6 (85.7) | 1 (14.3) |
Hypoglycaemia (MB-Stix < 3 mmol/L or clinical improvement after iv glucose) | 557 (10.3) | 278 (49.9) | 279 (50.1) |
Hb g/dl: Mean: 6.5, IQR (4.8–8.8) | 6.5 (4.6–8.8) | 6.8 (4.6–8.8) | |
BUN mg/dl: Mean 13, IQR: 9–20) | 13 ( 9−21) | 13 (9 –20) | |
Base excess: Mean − 8.78, IQR:—13 to − 4) | – 7 (−13 to − 4) | – 8 (−8 to − 4) |
Prognostic factors of metabolic acidosis
Variable | Sample size: 5425 | Univariable analysis | Multivariable analysis | |||||
---|---|---|---|---|---|---|---|---|
N (%) | Severe Metabolic Acidosis N (%) | Odds ratio | 95% CI | P-Value | Odds ratio | 95% CI | P Value | |
Gender: female (reference) and male | 2611 (48.1) | 1143 (51.3) | ||||||
2815 (51.9) | 1153 (48.9) | 0.91 | 0.81–1.02 | 0.11 | 0.92 | 0.19–4.55 | 0.92 | |
Age | 5426 | 0.78 | 0.76–0.81 | < 0.001 | 0.79 | 0.76–0.83 | < 0.001 | |
Coma (BCS < = 2) | 1823 (33.6) | 776 (50.6) | 1.03 | 0.91–1.16 | 0.646 | 1.72 | 1.17–2.51 | 0.005 |
Prostration | 2974 (54.8) | 1299 (52.3) | 1.21 | 1.07–1.36 | 0.002 | 1.88 | 1.35–2.59 | < 0.001 |
Convulsions (> 30 min) | 169 2(31.2) | 623 (43.4) | 0.68 | 0.60–0.77 | < 0.001 | 0.7 | 0.53–0.93 | 0.012 |
Decompensated shock: systolic BP < 70mhg | 178 (3.3) | 110 (71.9) | 2.62 | 1.84–3.75 | < 0.001 | 1.46 | 0.66–3.32 | 0.352 |
Respiratory distress | 867 (15.9) | 498 (67.8) | 2.39 | 2.03–2.83 | < 0.001 | 1.46 | 1.02–2.1 | 0.039 |
Deep breathing | 938 (17.3) | 731 (86.3) | 8.74 | 7.11 –10.74 | < 0.001 | 3.94 | 2.51–6.2 | < 0.001 |
Black water fever (haemoglobinuria) | 237 (4.4) | 73 (40.6) | 0.67 | 0.49–0.91 | 0.009 | 1.28 | 0.78–2.11 | 0.34 |
Symptomatic anaemia | 114 (2.1) | 55 (56.12) | 1.28 | 0.86–1.92 | 0.23 | |||
Anuria / Oliguria | 7 (0.1) | 7 (100) | 1 | * | * | |||
Hyperparasitaemia | 100 (1.8) | 40 (42.6) | 0.73 | 0.48–1.11 | 0.14 | |||
Mild anaemia (< 10—5) | 2705 (55.0) | 1139 (45.3) | 1.21 | 1.02–1.43 | 0.027 | 0.73 | 0.54–0.98 | 0.04 |
Severe anaemia (< 5) | 1431 (29.1) | 841 (64.2) | 2.6 | 2.16–3.13 | < 0.001 | 0.79 | 0.55–1.12 | 0.19 |
Uraemia (BUN > 20) | 1110 (24.3) | 800 (73.4) | 3.55 | 3.05-–4.13 | < 0.001 | |||
Hypoglycaemia | 557 (10.3) | 434 (88.4) | 9.11 | 6.87–12.09 | < 0.001 | 5.16 | 2.74–9.75 | < 0.001 |
Prognostic factors of uraemia
Variable | Sample size: 5425 | Univariable analysis | Multivariable analysis | |||||
---|---|---|---|---|---|---|---|---|
N (%) | Acute kidney injury N(%) | Odds Ratio | CI 95% | P-value | Odds Ratio | CI 95% | P-value | |
Age (Mean: 2 years IQR:25th -75th: 1–4) | 1.04 | 1.01–1.07 | 0.003 | 1.08 | 1.05—1.13 | < 0.001 | ||
Gender: female (reference), male | 2611 (48.1) | 533 (24.1) | 1.03 | 0.89—1.18 | 0.688 | 1 | 0.86—1.16 | 0.97 |
Coma (BCS < = 2) | 1823 (33.6) | 436 (28.8) | 1.42 | 1.23–1.63 | < 0.001 | 3.18 | 2.36—4.27 | < 0.001 |
Severe prostration | 2974 (54.8) | 574 (23.1) | 0.86 | 0.75–0.99 | 0.034 | 1.78 | 1.37—2.30 | < 0.001 |
Convulsions (> 30 min) | 1692 (31.2) | 293 (20.6) | 0.74 | 0.63–0.86 | < 0.001 | 0.83 | 0.68—1.02 | 0.075 |
Decompensated shock | 178 (3.3) | 59 (39.3) | 2.07 | 1.48–2.89 | < 0.001 | 1.89 | 1.31—2.74 | 0.001 |
Respiratory distress | 867 (15.9) | 198 (27.1) | 1.19 | 0.99–1.43 | 0.056 | 1.1 | 0.89—1.35 | 0.366 |
Deep breathing | 938 (17.3) | 255 (30.9) | 1.5 | 1.27–1.78 | < 0.001 | 2.05 | 1.65—2.55 | < 0.001 |
Black water fever (haemoglobinuria) | 237 (4.4) | 58 (32.0) | 1.49 | 1.08—2.05 | 0.014 | 1.58 | 1.09—2.27 | 0.014 |
Severe jaundice | 114 (2.1) | 49 (50) | 3.21 | 2.15– 4.79 | < 0.001 | 3.46 | 2.21- 5.43 | < 0.001 |
Anuria /Oliguria | 7 (0.1) | 6 (85.7) | 18.75 | 2.25–155.9 | 0.007 | |||
Hyperparasitaemia | 100 (1.8) | 14 (15.6) | 0.57 | 0.32 –1.01 | 0.053 | |||
Mild anaemia (< 10 −5) | 2705 (55.0) | 593 (23.6) | 1.54 | 1.24- 1.91 | < 0.001 | 1.28 | 1.01—1.62 | 0.04 |
severe anaemia (> 5) | 1431 (29.1) | 393 (29.9) | 2.13 | 1.69–2.67 | < 0.001 | 1.77 | 1.36—2.29 | < 0.001 |
Base excess: More than -8 mmol/L (reference) | 2286 (49.9) | 290 (12.9) | ||||||
Severe metabolic acidosis | 2296 (50.1) | 800 (35.6) | 3.73 | 3.21 – 4.33 | < 0.001 | |||
Blood Glucose: hypoglycaemia: < 3 mmol/L), No Hypoglycaemia (Reference) | 557 (10.3) | 223 (45.7) | 3.02 | 2.49–3.67 | < 0.001 | 2.77 | 2.22—3.46 | < 0.001 |