Actively Recruiting

Phase 3
Age: 1Month - 59Months
All Genders
NCT04750070

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

Led by International Centre for Diarrhoeal Disease Research, Bangladesh · Updated on 2025-04-16

135

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

Sponsors

I

International Centre for Diarrhoeal Disease Research, Bangladesh

Lead Sponsor

U

University of British Columbia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Month - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children of either sex with acute malnutrition and diarrhea
  • Age between 1 month and 59 months
  • Children with cerebral palsy and/or developmental delay or Down Syndrome with or without heart diseases
  • Fluid refractory shock
  • Consent from the caregivers or parents
Not Eligible

You will not qualify if you...

  • Having a rare blood group (Rh negative blood groups if donor is not available)
  • Child requiring cardio-pulmonary resuscitation during screening or having gasping respiration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icddr,B

Dhaka, Bangladesh, 1000

Actively Recruiting

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Research Team

M

Monira Sarmin, MBBS, MCPS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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