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

Who is this study for? Patients with Septic Shock
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 4
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Bangladesh
Icddr,B
RECRUITING
Dhaka
Contact Information
Primary
Monira Sarmin, MBBS, MCPS
drmonira@icddrb.org
+8801718596947
Time Frame
Start Date: 2021-08-17
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 135
Treatments
Active_comparator: Blood Transfusion and Dopamine arm
Children in this group (Treatment plan A) will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. In addition, they will 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)
Experimental: Blood Transfusion and Adrenaline arm
Children in this group (Treatment plan B) will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. In addition, they will 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)
Related Therapeutic Areas
Sponsors
Collaborators: Muhimbili University of Health and Allied Sciences, University of British Columbia
Leads: International Centre for Diarrhoeal Disease Research, Bangladesh

This content was sourced from clinicaltrials.gov