Fluid Expansion As Supportive Therapy in critically ill African children

ISRCTN	ISRCTN69856593
DOI	https://doi.org/10.1186/ISRCTN69856593
Protocol serial number	MRC ref: G0801439
Sponsor	Imperial College of Science, Technology and Medicine (UK)
Funder	Medical Research Council (UK) (ref: G0801439)

Submission date: 29/11/2008
Registration date: 21/01/2009
Last edited: 17/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kathryn Maitland
Scientific

KEMRI Wellcome Trust Unit
Kilifi
P.O Box 230-801
Kenya

Phone	+254 41 7522063
Email	kmaitland@kilifi.kemri-wellcome.org

Study information

Primary study design	Interventional
Study design	Open randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised trial of fluid resuscitation strategies in African children with severe febrile illness and clinical evidence of impaired perfusion
Study acronym	FEAST
Study objectives	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.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Severe illness with shock due to sepsis or severe malaria
Intervention	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
Intervention type	Other
Primary outcome measure(s)	In-hospital mortality at 48 hours after randomisation.
Key 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)
Completion date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	60 Days
Upper age limit	12 Years
Sex	All
Target sample size at registration	2880
Total final enrolment	3141
Key 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
Key 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
Date of first enrolment	15/12/2008
Date of final enrolment	01/12/2011

Locations

Countries of recruitment

Kenya
Tanzania
Uganda

Study participating centre

KEMRI Wellcome Trust Unit

Kilifi
P.O Box 230-801
Kenya

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/06/2011		Yes	No
Results article	results	14/03/2013		Yes	No
Results article	results	01/07/2019	17/06/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/06/2019: Publication reference and total final enrolment added.