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

ConditionsShock HypovolemicShock, SepticBlood TransfusionAdrenalineDopamine
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Blood and Dopamine

    Drug

    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)

  • Blood and adrenaline

    Drug

    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)

Treatment groups

135 Participants
are divided into 2 treatment groups
Group A: Blood Transfusion and Dopamine armActive comparator 1 intervention
Group B: Blood Transfusion and Adrenaline armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Case fatality rate

Number of mortalities among acutely malnourished children presenting with diarrhea and fluid refractory shock who would receive WHO standard fluid therapy followed by blood transfusion with either dopamine or adrenaline.

Time frame
28 days (± 3 days)

Secondary outcomes

1

Treatment failure rates

Number of children where we failed to achieve the goal of resuscitation after starting any one of the interventions

Time frame
Through study completion, an average of 7 days
2

Need for mechanical ventilation

Number of children who would require mechanical ventilation

Time frame
Through study completion, an average of 7 days
3

Heart failure

Number of children who developed heart failure. Heart failure will be assessed on the basis of - age-specific tachypnea, tachycardia, enlarged tender liver, pedal edema, basal crackles and/or gallop and response to furosemide (combination of findings).

Time frame
Through study completion, an average of 7 days
4

Length of ICU stay

Time a child stays in ICU

Time frame
Through study completion, an average of 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Centre for Diarrhoeal Disease Research, Bangladesh

Lead sponsor

University of British Columbia

Collaborator

Muhimbili University of Health and Allied Sciences

Collaborator

Source ClinicalTrials.gov
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