FEAST

Fluid Expansion as Supportive Therapy Trial (FEAST)

Study acronym

FEAST

Background

Severe infections such as malaria and sepsis remain important causes of childhood death in sub-Saharan Africa. Many deaths occur within the first 24 hours after hospital admission.

In high-resource settings, children with severe infection and shock commonly receive rapid intravenous fluid boluses to improve blood circulation. Before FEAST, there was limited evidence about the safety and effectiveness of this practice in African hospitals without intensive-care facilities.

Study purpose

FEAST investigated whether rapid intravenous fluid administration could reduce early mortality among critically ill African children with severe febrile illness and clinical evidence of impaired circulation.

The trial also compared albumin and saline as fluids for resuscitation.

Study design

FEAST was an open-label, multicentre, randomised controlled trial conducted in six hospitals across Uganda, Kenya and Tanzania.

Children without severe hypotension were randomly assigned to receive:

Most children assigned to a bolus received 20 ml/kg over one hour. A second bolus could be administered when signs of impaired circulation persisted.

Children with severe hypotension were assigned to either albumin or saline because withholding a bolus from this group was considered inappropriate.

Study population

The trial enrolled 3,170 children aged over 60 days and under 12 years. Participants had severe febrile illness, impaired consciousness or respiratory distress, and clinical evidence of impaired circulation.

Malaria was the most common diagnosis, although bacterial infections and other serious illnesses were also represented. Children with severe malnutrition, gastroenteritis, burns, trauma or substantial blood loss were excluded. UCL Innovative Clinical Trials Unit

Study sites

The trial was conducted at:

Mbale Regional Referral Hospital’s participation made FEAST an important part of MCRI’s history of collaborative paediatric emergency-care research.

Study leadership

Professor Kathryn Maitland was the Chief Investigator.

Key Ugandan investigators included Professor Sarah Kiguli, Dr Robert Opoka, Dr Charles Engoru and Professor Peter Olupot-Olupot. The study was implemented through the FEAST Trial Group and supported by collaborating investigators and clinical teams across the three participating countries.

Sponsor and funder

Imperial College London sponsored the trial.

The United Kingdom Medical Research Council funded the study through the MRC–Department for International Development concordat under grant G0801439. Baxter Healthcare donated the resuscitation fluids but did not participate in the study’s design, analysis or publication decisions. FEAST follow-up analysis

Primary outcome

The primary outcome was death from any cause within 48 hours after randomisation.

Secondary outcomes included mortality at four weeks, neurological complications, adverse events and clinical responses to the assigned fluid strategy.

Principal findings

The study found that children who received albumin or saline fluid boluses had higher mortality than children who received maintenance fluids without a bolus.

By 48 hours, mortality was approximately 11% in both bolus groups compared with 7% in the maintenance-fluid group. Fluid boluses therefore produced an absolute increase in mortality of approximately three deaths for every 100 children treated.

The increased mortality occurred with both albumin and saline, with no evidence that either bolus fluid was safer. The trial was stopped early in January 2011 following advice from the independent Data and Safety Monitoring Committee. New England Journal of Medicine article

Importance of the study

The FEAST findings challenged the assumption that rapid fluid resuscitation was beneficial for all children with severe infection and impaired circulation.

The results demonstrated that fluid-management practices developed in well-resourced intensive-care settings could not automatically be transferred to resource-limited hospitals. Subsequent analysis found a 3.3% absolute increase in mortality by 48 hours and a 3.4% increase by 28 days among children receiving boluses. Published follow-up analysis

The results do not apply to children who require fluid replacement because of diarrhoeal dehydration, burns, trauma or major blood loss, as these groups were excluded from the trial.

Study period

The trial began in January 2009 and was stopped early in January 2011 because of evidence of harm in the fluid-bolus groups.

The principal findings were published in the New England Journal of Medicine in June 2011. PubMed record

Trial registration

The trial was registered as ISRCTN69856593 on 15 December 2008.

Ethics and regulatory approvals

Approvals were obtained from:

Study status

FEAST is a completed study. Recruitment was closed in January 2011, and the principal results and subsequent analyses have been published.

About

Ms. Adyango Catherine is a Human Resource Manager and Senior Grants Professional with over 15 years of experience in managing multimillion-dollar donor portfolios, project operations, and organizational systems strengthening. She currently serves as Human resource Manager at Mbale Clinical Research Institute (MCRI), where she leads in Human resource management,  donor compliance, project operations, and institutional capacity building.

At MCRI, Catherine has combined her expertise in grant management and human resources to establish efficient systems that support both research and staff welfare. She played a pivotal role in championing organizational culture reforms, developing HR policies, strengthening staff welfare schemes, and promoting inclusive recruitment processes. She also streamlined adoption of a Human Resource Management Information System (HRMIS/ESS), which reduced administrative bottlenecks and improved efficiency across teams.

Her academic background includes a Postgraduate Diploma in Human Resource Management (Uganda Management Institute), an MSc in Health Services Management, and a bachelor’s degree in business administration & management. Catherine is also pursuing ACCA training, demonstrating her commitment to continuous professional growth.

Catherine’s career reflects a strong commitment to strategic leadership, staff development, and inclusive programming, with a proven ability to balance donor expectations and human resource needs. Her work at MCRI has significantly contributed to building sustainable research capacity, enhancing compliance systems, and creating a supportive work environment that empowers both researchers and administrative staff.

About

Denis Amorut serves as the Study Site Coordinator at the Mbale Clinical Research Institute’s Soroti Site. He is a qualified Registered Nurse with a Bachelor of Science in Health Services Management from the Islamic University in Uganda and a Diploma in Comprehensive Nursing from Soroti School of Registered Comprehensive Nursing. Additionally, he is currently pursuing an Advanced Postgraduate Diploma in Clinical Research & Quality Assurance at James Lind Institute, showcasing his commitment to advancing his expertise in clinical research. Denis has an extensive professional background with 12 years in clinical nursing practice and 11 years dedicated to clinical research. He is registered with the Uganda Midwives and Nurses Council, highlighting his professional standing in the healthcare sector.
 
Throughout his career, Denis has held significant positions such as Trial Manager since November 2021 and previously as Study Site Coordinator at Soroti Regional Referral and Teaching Hospital from 2008 to October 2021. He also serves as a member of the Medicine and Therapeutic Committee at the same hospital since 2018. Denis has enriched his knowledge and skills through numerous online courses and certifications in areas like research ethics, data management for clinical studies, Good Clinical Practice (GCP), and managing health emergencies like Covid-19. His involvement in various research studies, including the TRACT study, and his roles in hospital committees further demonstrate his dedication to both practice and research in healthcare, focusing on improving patient care through evidence-based practices.

About

Ms. Linda Isabirye serves as the Public and Community Engagement Officer at MCRI, where her role encompasses a variety of tasks aimed at enhancing the Institute’s interaction with both internal and external communities. Her work is divided into two primary focuses: public engagement, where she communicates the Institute’s research and ideas to the public, and community engagement, where she assists others in conducting research and achieving their objectives.

In her community engagement efforts, Linda is involved in developing and sustaining a public engagement and involvement framework for the research program. She identifies local opportunities for community collaboration, nurturing relationships with MCRI’s research scientists, staff, and the broader community.

With over two years of experience, she has worked extensively with diverse community stakeholders. Her responsibilities include coordinating activities for the Community Advisory Board (CAB), designing, and overseeing the execution of Community Engagement (CE) initiatives. These initiatives are crucial for identifying, recruiting, and retaining volunteers, engaging community leadership, and supporting the formation and operation of community peer groups. This includes working with study participants, family support groups, and youth and adolescent groups, among others.

About

Rita Muhindo holds a MSc. Molecular Biology from Staffordshire University, UK. She attained her BSc. Biomedical Laboratory Science and Technology degree from Makerere University and an Advanced Diploma in Health Services Management from Islamic University in Uganda. She joined Mbale Clinical Research Institute in July 2011 as a laboratory technologist participating in setting up various laboratory assays for all clinical trials at the MCRI.

She is currently the laboratory manager of MCRI, a role which involves supervision all laboratory research activities at MCRI main and satellite laboratories. She has over twelve years of experience in managing laboratory clinical research and diagnostics service delivery across several key disciplines including molecular, immunology, hematology, microbiology and clinical chemistry.

She has keen interest in understanding the prevalence of red cell polymorphisms present in Ugandan donor populations. Her main focus of her MSc project was on the prevalence of Glucose-6-Phosphate dehydrogenase deficiency, α-thalassaemia and Haemoglobin S among Ugandan donors. Rita is also keen to explore the effects of these polymorphisms on the resolution of severe anaemia.

About

Dr. Charles Benard Okalebo is a highly qualified professional with a B. Pharm, an MPH, and currently a fellow in Infectious Disease and Field Epidemiology under the EDCTP-funded IDEA fellowship. His background as a pharmacist and public health specialist, combined with his role as a Quality Assurance Officer, has provided him with extensive experience in clinical research. This diverse training has honed his skills in assessing healthcare gaps, identifying problems, and designing projects to address these deficiencies. Dr. Okalebo values accuracy, integrity, quality, and career growth above all.
 
He is an experienced and determined professional in conducting clinical trials for both infectious and non-infectious diseases. With eight years in the research field, he has served as a Pharmacist and Quality Assurance Officer at the Mbale Clinical Research Institute, focusing on various types of clinical trials related to infectious diseases. His involvement spans across all phases of clinical trials (I-III), including protocol design, review, and implementation; navigating regulatory approval processes; managing investigational medicinal products (IMP); monitoring studies; establishing and implementing Quality Management processes; pharmacovigilance; and leading training sessions on the ethical conduct of research. The trials he has participated in include TRACT (ISRCTN84086586), GASTROSAM (ISRCTN76149273), PAC (ISRCTN11594437), FLACSAM (ISRCTN18051843), MIMBLE (ISRCTN10309022), and TABS (ISRCTN49726849) studies.
 
Dr. Okalebo is a dedicated researcher with a keen interest in advancing his career in pharmaco-epidemiology, statistics, and pharmacovigilance.

About

Felix Opio joined the Mbale Clinical Research Institute (MCRI) in April 2014 as Data Manager under the REACH (Realizing Effectiveness Across Continents with Hydroxyurea) ClinicalTrials.gov NCT01966731) which is a prospective, Phase I/II open-label trial of hydroxyurea designed to evaluate the feasibility, safety, long-term risks and benefits of hydroxyurea treatment for children with SCA in four sub-Saharan African countries (Mable Uganda,Kilifi Kenya, Luanda Angola and Kinshasa DRC).

He holds a Bachelor of Science in Computer Science from Gulu University, a post graduate diploma in Monitoring and Evaluation from Uganda Management Institute (UMI), Certificate in Project Management Professional from Devimpact Institute Kenya and various other certification in Clinical database development.

He Has 9 years of experience in Clinical Database design and Management, He is Currently overseeing data management work for the REACH study and all the day to day activities of the Project, He is also a member of the internal Clinical Trial Monitoring Unit and A chairperson Procurement Committee for Mbale Clinical Research Institute.

About

Ebitu Caleb Daniel serves as an I.T Support Officer at the Mbale Clinical Research Institute. He is recognized as an accomplished network and systems administrator, who takes pleasure in applying his skills to support and contribute to the technological advancement of research within the institution.
 
Ebitu graduated from Uganda Christian University Mukono with a Bachelor’s degree in Computer Science. Over the years, he has also acquired various certifications including CCNA, Information Security, Google Cloud Developer, PMP (Telecom), and Federated Identity Management.

About

Laban has accumulated over four years of experience in managing research financial processes since joining the Mbale Clinical Research Institute on July 1, 2019, as an Accounts Assistant. This experience complements his extensive background of over ten years in the banking sector, where he has previously worked for two banks in roles involving people management, cash management, internal controls, and accountability.

He holds a Bachelor’s degree in Business Studies, specializing in Accounting, from the Islamic University of Uganda. He is currently pursuing a Certificate of Public Accountants (CPA) from the Institute of Certified Public Accountants of Uganda (ICPAU), with only two papers remaining to complete the course.

Driven by an ambition to advance his career in accounting and expand his experience in research-related accounting managed by well-established systems and processes, he believes that MCRI is the ideal place for his professional growth.