Actively Recruiting
Management of Shock in Children With SAM or Severe Underweight and Diarrhea
Led by International Centre for Diarrhoeal Disease Research, Bangladesh · Updated on 2025-04-16
135
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
Sponsors
I
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Management of Shock in Children With SAM or Severe Underweight and Diarrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children of either sex with acute malnutrition and diarrhea
- Age between 1 month and 59 months
- Children with cerebral palsy and/or developmental delay or Down Syndrome with or without heart diseases
- Fluid refractory shock
- Consent from the caregivers or parents
You will not qualify if you...
- Having a rare blood group (Rh negative blood groups if donor is not available)
- Child requiring cardio-pulmonary resuscitation during screening or having gasping respiration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icddr,B
Dhaka, Bangladesh, 1000
Actively Recruiting
Research Team
M
Monira Sarmin, MBBS, MCPS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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