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

RecruitingPhase 3Ages 1 Month - 59 MonthsAllInternational Centre for Diarrhoeal Disease Resea…
NCT04750070 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 exampl

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📋 Eligibility rules (as published)
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: 1. Having a rare blood group (Rh negative blood groups provided that donor is not available) 2. A child requiring cardio-pulmonary resuscitation during screening or having gasping respiration
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What it tests

  • Blood and Dopamine
  • Blood and adrenaline
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Where

1 site
Icddr,B
Dhaka, Bangladesh
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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