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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-59
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

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

135 Participants
are divided into 2 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