Randomized controlled trial of interventions for treatment of shock in children with severe acute malnutrition and cholera or other dehydrating diarrheas

Children with severe acute malnutrition and cholera or any other dehydrating diarrhea often present with shock which can be due to either severe dehydration or severe sepsis. While it is challenging to differentiate between severe dehydration and septic shock, more than 40% children with SAM and shock die despite initial intravenous fluid resuscitation. This will be a randomized clinical trial comparing two interventions on children with SAM and shock who do not respond clinically (recovering from shock) to intravenous fluids for resuscitation. The two interventions are dopamine and blood transfusion (recommended by WHO). Although these interventions are practiced in some centres, they are not backed by evidence from RCTs. This proposed RCT will be done in icddr,b Dhaka Hospital that treats 150,000 patients each year with 20% suffering from cholera. The trial, led by icddr,b clinicians and scientists with decades of experience in treating SAM and cholera, will enroll 174 children less than 5 years old with SAM and cholera or any other dehydrating diarrhea plus shock over a period of 2 years. Outcome variables will include rates of case fatality and treatment failure, incidence of heart failure during intervention, need for mechanical ventilation, length of hospitalization, and time-to-achieve recovery.