| Methods |
Multicentre open, randomised, controlled study |
| Participants |
Children (n=3170) aged between 60 days and twelve years of age, with severe febrile illness, randomly assigned within two strata (stratum A was children with severe febrile illness and impaired perfusion but without severe hypotension ‐ stratum B was children with severe hypotension). |
| Interventions |
Children were randomly allocated to rapid volume replacement over the course of 1 hour with either:
1) 20 ml 5% Human Albumin solution per kg body weight (n=1063)
2) 20 ml 0.9% Saline solution per kg body weight (n=1063) |
| Outcomes |
Mortality at 4 weeks after randomisation |
| Notes |
Children (n=1044) assigned to no treatment were not included in the analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Trial numbers kept inside opaque, sealed envelopes. Opened in numerical order by clinician. |
