A randomised trial of fluid resuscitation strategies in African children with severe febrile illness and clinical evidence of impaired perfusion

Imperial College of Science, Technology and Medicine (UK)0 sites3,141 target enrollmentJanuary 21, 2009

Overview

Registry

who.int

Start Date

January 21, 2009

End Date

December 1, 2011

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Imperial College of Science, Technology and Medicine (UK)

•Children (both males and females, age range \>60 days and \<12 years) with severe illness and clinical evidence of impaired perfusion in whom there is uncertainty as to the benefits of immediate fluid resuscitation and what type of fluid to give.
•Severe illness and impaired perfusion defined as follows:
•1\. Severe illness: one or more of the following:
•1\.1\. Impaired consciousness: prostration or coma
•1\.2\. Respiratory distress
•Prostration: inability to sit unsupported, or to breast feed if \< 9months
•Coma: inability to localise a painful stimulus
•Respiratory distress: Deep breathing or increased work of breathing
•2\. Impaired perfusion: one or more of the following:
•2\.1\. Capillary refill time \>2s

•One or more of the following at admission:
•1\. Severe acute malnutrition
•2\. Gastroenteritis
•3\. Conditions where intravascular volume expansion is contraindicated, namely chronic renal failure, pulmonary oedema
•4\. Non\-infectious causes of severe illness: trauma, burns, intoxication
•5\. Children who have already received volume expansion using an isotonic volume expander during the current illness
•Severe malnutrition: visible severe wasting and/or kwashiorkor
•Gastroenteritis: \>3 watery stools in previous 24 hours
•Pulmonary oedema: oxygen saturation \<90% on pulse oximetry plus bilateral basal crepitations