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Fluid Expansion As Supportive Therapy in critically ill African children
ISRCTN ISRCTN69856593
DOI 10.1186/ISRCTN69856593
ClinicalTrials.gov identifier
EudraCT number
Public title Fluid Expansion As Supportive Therapy in critically ill African children
Scientific title A randomised trial of fluid resuscitation strategies in African children with severe febrile illness and clinical evidence of impaired perfusion
Acronym FEAST
Serial number at source MRC ref: G0801439
Study hypothesis In hospitals throughout sub-Saharan Africa, mortality from malaria and other severe infections in childhood remains at 15-30%, with over 50% of deaths occurring within 24 hours of admission. Currently, antimalarial and antimicrobial drugs are the mainstay of treatment, with little consideration being given to the use of adjunctive supportive therapies. There is considerable debate about the degree to which intravascular volume depletion (hypovolaemia) contributes to the pathophysiology of malaria and other severe infections, and clinical practice varies widely across the continent. To resolve the continuing uncertainty, this multi-centre randomised clinical trial will evaluate different fluid resuscitation strategies in children presenting to hospital with severe febrile illness and clinical evidence of impaired perfusion, with the intention of generating data of practical value to clinicians working in resource-poor settings in Africa.
Lay summary Not provided at time of registration
Ethics approval 1. Imperial College Research Ethics Committee (UK), approved in August 2008 (ref: ICREC_8_1_1)
2. Kenya Medical Research Institute (KEMRI) National Ethics Review Committee (Kenya), approved in July 2008 (ref: SCC 1355)
3. National Ethics Review Committee, Makarere University (Uganda) approved in April 2008
4. NIMRI Ethics Review Board (Tanzania), approved in September 2008 (ref: 748)
Study design Open randomised controlled trial
Countries of recruitment Kenya, Tanzania, Uganda
Disease/condition/study domain Severe illness with shock due to sepsis or severe malaria
Participants - inclusion criteria 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
2.2. Lower limb temperature gradient
2.3. Weak radial pulse volume
2.4. Severe tachycardia

Severe tachycardia: if <12 months: >180 bpm; 12 months to 5 years: >160 bpm; >5 years: >140 bpm
Participants - exclusion criteria 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
Anticipated start date 15/12/2008
Anticipated end date 01/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.
Target number of participants 2,880
Interventions This is a three-arm randomised open controlled trial comparing two active fluid resuscitation strategies to control (no bolus). 2,880 children will be assigned in a ratio of 1:1:1 to one of the three fluid management arms; 144 with decompennsated shock will be randomised to human albumin solution (HAS) or saline.

Three resuscitation strategies:
1. Immediate volume resuscitation with normal (0.9%) saline
2. Immediate volume expansion with 5% human albumin solution (HAS)
3. No immediate volume expansion (control)

Children will be assessed for neurological deficit at 28 days from date of randomisation. A further assessment will be conducted at six months only in children with a persistent neurological sequelae at 28 days.

Please use the following contact details to request a patient information sheet:
Study Coordinator: Dr Mukami Mbogo
KEMRI Wellcome Trust Programme
P.O. Box 230-80108
Kilifi
Kenya
Tel: +254 41 7522063
Fax: +254 41 7522390
Email: mmbogo@kilifi.kemri-wellcome.org
Primary outcome measure(s) In-hospital mortality at 48 hours after randomisation.
Secondary outcome measure(s) 1. Mortality at 4 weeks after randomisation
2. Mortality or neurological sequelae at 4 weeks after randomisation
3. Neurological sequelae at 4 weeks after randomisation
4. Persistent neurological sequelae at 6 months after randomisation
5. Development of hypotensive shock within 48 hours of randomisation
6. Adverse event within 48 hours of randomisation (pulmonary oedema, intracranial hypertension, severe allergic reaction in those receiving albumin)
Sources of funding Medical Research Council (UK) (ref: G0801439)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21615299
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23496872
Contact name Dr  Kathryn  Maitland
  Address KEMRI Wellcome Trust Unit
  City/town Kilifi
  Zip/Postcode P.O Box 230-801
  Country Kenya
  Tel +254 41 7522063
  Fax +254 41 75290
  Email kmaitland@kilifi.kemri-wellcome.org
Sponsor Imperial College of Science, Technology and Medicine (UK)
  Address Exhibition Road
  City/town London
  Zip/Postcode SW7 2AZ
  Country United Kingdom
  Email m.cranmer@imperial.ac.uk
  Sponsor website: http://www3.imperial.ac.uk/
Date applied 29/11/2008
Last edited 20/03/2013
Date ISRCTN assigned 21/01/2009
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