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

Diarrhea is one of the leading causes of under-five childhood mortality and accounts for 8% of 5.4 million global under-5 deaths. The coexistence of sepsis and hypovolemic shock in children with severe acute malnutrition (SAM) having diarrhea is common. At Dhaka hospital of icddr,b, the death rate is as high as 40% and 69% in children with severe sepsis and septic shock respectively with co-morbidities such as severe malnutrition. The conventional management of SAM children with features of severe sepsis recommended by WHO includes administration of boluses of isotonic saline followed by blood transfusion in unresponsive cases with septic shock; whereas the Surviving Sepsis Campaign (SSC) guideline recommends vasoactive support. To date, no study has evaluated systematically the effects of inotrope(s) and vasopressor or blood transfusion in children with dehydrating diarrhea (for example, in cholera) and SAM having shock and unresponsive to WHO standard fluid therapy. This randomized trial will generate evidence whether inotrope and vasopressor or blood transfusion should be selected for severely malnourished children having hypotensive shock and who failed to respond to WHO standard fluid bolus.

NCT Number	NCT04750070
Lead Sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh Collaborators: University of British Columbia, Muhimbili University of Health and Allied Sciences
Conditions	Shock Hypovolemic, Shock, Septic, Blood Transfusion, Adrenaline, Dopamine
Enrollment	135 participants
Start Date	2021-08-17
Primary Completion	2025-07-31 (estimated)
Study Completion	2025-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-16