RecruitingPhase 3NCT04750070

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

Randomized Controlled Trial of Dopamine, Adrenaline, and Blood Transfusion for Treatment of Fluid Refractory Shock in Children With Severe Acute Malnutrition or Severe Underweight and Cholera or Other Dehydrating Diarrheas


Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Enrollment

135 participants

Start Date

Aug 17, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 MonthMax Age: 59 Months

Inclusion Criteria5

  • 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
  • Consent from the caregivers/parents

Exclusion Criteria2

  • 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

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Interventions

DRUGBlood and Dopamine

Children in this group will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. They will also receive dopamine, 8 microgram/kg.min (increasing the dose after 15 minutes to 12 microgram/kg/min to a maximum of 15 microgram/kg/min)

DRUGBlood and adrenaline

Children in this group will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. They will also receive adrenaline, 0.1 microgram/kg/min (increasing the dose after 15 minutes to 0.2 microgram/kg.min to a maximum of 0.3 microgram/kg.min)


Locations(1)

Icddr,B

Dhaka, Bangladesh

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NCT04750070


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