Fluid Expansion As Supportive Therapy in critically ill African children

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Kathryn Maitland

ORCID ID

Contact details

KEMRI Wellcome Trust Unit
Kilifi
P.O Box 230-801
Kenya
+254 41 7522063
kmaitland@kilifi.kemri-wellcome.org

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

MRC ref: G0801439

Scientific title

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

Acronym

FEAST

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.

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)

Study design

Open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.

Condition

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

In-hospital mortality at 48 hours after randomisation.

Secondary outcome measures

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)

Overall study start date

15/12/2008

Overall study end date

01/12/2011

Reason abandoned (if study stopped)

Participant 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

Participant type(s)

Patient

Age group

Child

Lower age limit

60 Days

Upper age limit

12 Years

Sex

Both

Target number of participants

2,880

Total final enrolment

3141

Participant 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

Recruitment start date

15/12/2008

Recruitment end date

01/12/2011

Countries of recruitment

Kenya, Tanzania, Uganda

Study participating centre

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

Organisation

Imperial College of Science, Technology and Medicine (UK)

Sponsor details

Exhibition Road
London
SW7 2AZ
England
United Kingdom
-
m.cranmer@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

ROR

https://ror.org/041kmwe10

Funder type

Government

Funder name

Medical Research Council (UK) (ref: G0801439)

Alternative name(s)

UK Medical Research Council, MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs