Fluid Expansion As Supportive Therapy in critically ill African children
| ISRCTN | ISRCTN69856593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69856593 |
| Secondary identifying numbers | MRC 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
Not provided at time of registration
Contact information
Dr Kathryn Maitland
Scientific
Scientific
KEMRI Wellcome Trust Unit
Kilifi
P.O Box 230-801
Kenya
| Phone | +254 41 7522063 |
|---|---|
| kmaitland@kilifi.kemri-wellcome.org |
Study information
| Study design | Open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the Interventions field to request a patient 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 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) |
| 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 |
Eligibility
| 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 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 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 |
Locations
Countries of recruitment
- Kenya
- Tanzania
- Uganda
Study participating centre
KEMRI Wellcome Trust Unit
Kilifi
P.O Box 230-801
Kenya
P.O Box 230-801
Kenya
Sponsor information
Imperial College of Science, Technology and Medicine (UK)
University/education
University/education
Exhibition Road
London
SW7 2AZ
England
United Kingdom
| m.cranmer@imperial.ac.uk | |
| Website | http://www3.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Medical Research Council (UK) (ref: G0801439)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
17/06/2019: Publication reference and total final enrolment added.
