About this trial
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.
Eligibility criteria
Qualifiers
Children of either sex with acute malnutrition and diarrhea
Age: 1-59 months
Children with cerebral palsy (CP) and/or developmental delay, Down Syndrome with or without heart diseases
Fluid refractory shock
Disqualifiers
Having a rare blood group (Rh negative blood groups provided that donor is not available)
A child requiring cardio-pulmonary resuscitation during screening or having gasping respiration
Trial design
Treatments tested in this trial
- Blood and Dopamine
- Blood and adrenaline
Treatment groups
Sponsors and collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
University of British Columbia
Collaborator
Muhimbili University of Health and Allied Sciences
Collaborator