Management of Shock in Children With SAM and Diarrhea
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators:
Muhimbili University of Health and Allied Sciences University of British Columbia