Management of Shock in Children With SAM or Severe Underweight and Diarrhea
Recruiting
Phase 3
Interventional Study
Shock Hypovolemic
Shock, Septic
Blood Transfusion
Adrenaline
Dopamine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 59 Months
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 135 (estimated)
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh · Other
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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-morbid…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Children of either sex with acute malnutrition and diarrhea
2. Age: 1-59 months
3. Children with cerebral palsy (CP) and/or developmental delay, Down Syndrome with or without heart diseases
4. Fluid refractory shock
5. Consent from the caregivers/parents
Exclusion Criteria:
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Contacts