GASTROSAM: Rethinking Hydration Strategies in Severe Acute Malnutrition
For over 25 years, treatment methods for children with severe acute malnutrition (SAM) and severe dehydration from gastroenteritis have been very different from those used for well-nourished children. Well-nourished children usually receive rapid intravenous (IV) fluids with saline over 3–5 hours to rehydrate them quickly. However, children with SAM typically get low-salt oral rehydration solutions (ORS), and IV fluids are only given if they go into shock.
This cautious approach is based on concerns that malnourished children’s hearts may not handle saline and IV fluids well. These concerns mostly come from expert opinion rather than strong scientific evidence. Despite these careful guidelines, death rates remain high. This raises the question of whether giving more IV fluids earlier might help improve survival.
To answer this important question, researchers from Médecins Sans Frontières (MSF), Imperial College London, and University College London (UCL) have worked together to carefully study the safety and effectiveness of IV rehydration in children with SAM and dehydration.
The GASTROSAM study, recently published in the New England Journal of Medicine, was conducted across Niger, Nigeria, Uganda, and Kenya. It involved 292 children aged 12 and under, hospitalized with severe acute malnutrition (SAM) and dehydration caused by diarrhea. Most participants were recruited from Médecins Sans Frontières (MSF)-supported sites.
The trial compared the safety of three rehydration strategies, with children randomly assigned to one of the following groups:
- Current WHO standard of care: Oral rehydration with IV fluids reserved only for cases of poor circulation (control group).
- Rapid IV rehydration: The standard approach typically used for well-nourished children.
- Slow IV rehydration: The same volume as the rapid IV group but administered more slowly.
As part of the GASTROSAM consortium, LuxOR played a crucial role in providing operational research support, particularly at the Maiduguri research site—coordinating teams, strengthening research capacity, and ensuring rigorous implementation across the study sites.
Dr. Temmy Sunyoto, Senior Operational Research Advisor, reflected on the challenges and resilience of the team:
Temmy and GASTROSAM team in Maiduguri
Running a clinical trial here is never simple: the 2024 malnutrition peak has stretched the hospital to its limits, torrential floods have cut off access, and community protests even forced us to pause recruitment. Yet, despite every setback, the Maiduguri team’s skill and determination shine through, driving research that will help transform care for the vulnerable children we serve.
After 96 hours, the trial found no difference in mortality between the intravenous (IV) rehydration groups and the standard oral rehydration strategy. Overall mortality was lower than expected, likely due to the close care and monitoring provided during the trial.
Crucially, no cases of heart failure or fluid overload were observed, indicating that IV rehydration was safe in children with SAM. Conversely, the oral rehydration strategy often required nasogastric tube insertion, which was associated with higher rates of vomiting and shock.
These findings suggest that current treatment guidelines could be simplified by removing distinctions between malnourished and well-nourished children in rehydration protocols, potentially leading to broader adoption of IV rehydration worldwide.