Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a phase II rehydration trial for severe dehydration: WHO plan C versus slow rehydration

Table 5 Serious adverse events recorded during the trial

	WHO plan C n = 61	GASTRO slow n = 61
Number of SAEs	3 (4.9%)	3 (4.9%)
Outcome of SAE
Resolved	1	1
Died	2 (3.3%)	2 (3.3%)
Relationship to study fluid
Unlikely to be related	2	3
Probably related	1	0
Nature of event
Pulmonary oedema^a	0	1
Cardiovascular collapse^b	2	1
Other:
Status Epilepticus (child with severe malarial anaemia)	1	0
Convulsions	0	1

^aDevelopment of hypoxia (PaO2 < 90%) with chest signs (crepitations or indrawing)
^bSigns of shock at the point of demise: severe tachycardia or bradycardia plus one of prolonged CRT > 2 s, cold peripheries or low systolic blood pressure

ISSN: 1741-7015