Randomized Controlled Trial of Dopamine, Adrenaline, and Blood Transfusion for Treatment of Fluid Refractory Shock in Children With Severe Acute Malnutrition or Severe Underweight and Cholera or Other Dehydrating Diarrheas

What this Trial Is About

Diarrhea is a major cause of death in children under five years old, especially when combined with severe acute malnutrition (SAM) and shock. This study evaluates the best treatment for children with SAM or severe underweight who have fluid refractory shock and diarrhea, comparing blood transfusion with dopamine versus blood transfusion with adrenaline after standard fluid therapy fails. The trial aims to reduce the high mortality rates seen in these children, particularly in settings like the Dhaka hospital where death rates are very high. The trial is a randomized, controlled study with two treatment groups. One group receives a blood transfusion at 10 mL/kg over 2-3 hours plus dopamine starting at 8 micrograms/kg/min, increasing as tolerated. The other group receives the same blood transfusion plus adrenaline starting at 0.1 micrograms/kg/min, also with dose escalation. Both groups receive hydrocortisone alongside the study treatments. The study focuses on children aged 1 to 59 months with severe malnutrition and fluid refractory shock. Participants will be monitored closely during the study for outcomes including death rate over 28 days, treatment failure, heart and lung function, need for mechanical ventilation, and length of hospital and ICU stay. Assessments include heart function measurements and blood pressure stabilization. The study involves follow-up for an average of seven days during hospitalization, with data collection on recovery time and survival. The total participation period extends through hospital discharge and includes safety monitoring.

Management of Shock in Children With SAM or Severe Underweight and Diarrhea