Managing shock in malnourished children with diarrhea
Official title: 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
Run by International Centre for Diarrhoeal Disease Research, Bangladesh · NCT04750070 · Data updated 2026-11-12
This study is testing whether blood transfusions and certain medications can help young children with severe malnutrition and diarrhea who are in shock feel better compared to regular fluid treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 1 Month to 59 Months |
| Sex | All |
| Enrollment | 135 (estimated) |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Status | Recruiting |
| Started | August 17, 2021 |
| Main results expected | July 31, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | April 16, 2025 |
| Trial ID | NCT04750070 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 1-59 months with acute malnutrition and diarrhea who are experiencing fluid refractory shock.
✕Probably not a fit
Patients who are in need of immediate cardiopulmonary resuscitation or have rare blood types without available donors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of blood transfusions and vasoactive medications like dopamine and adrenaline in treating children aged 1-59 months who are suffering from severe acute malnutrition and experiencing fluid refractory shock due to diarrhea. The study aims to address the high mortality rates associated with severe sepsis and septic shock in this vulnerable population, particularly in the context of existing WHO treatment guidelines. By comparing conventional fluid therapy with these alternative interventions, the trial seeks to fill a critical knowledge gap regarding optimal management strategies for these children.
Why it matters
Potential benefit: If successful, this study could significantly reduce mortality rates in malnourished children suffering from shock due to diarrhea.
How similar studies have gone: While similar studies have highlighted the challenges of managing severe sepsis in malnourished children, this specific approach involving inotropes and blood transfusions in the context of dehydrating diarrhea is novel and has not been systematically evaluated before.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children of either sex with acute malnutrition and diarrhea 2. Age: 1-59 months 3. Children with cerebral palsy (CP) and/or developmental delay, Down Syndrome with or without heart diseases 4. Fluid refractory shock 5. Consent from the caregivers/parents Exclusion Criteria: 1. Having a rare blood group (Rh negative blood groups provided that donor is not available) 2. A child requiring cardio-pulmonary resuscitation during screening or having gasping respiration
Where it's running
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Icddr,B
Dhaka, Bangladesh Recruiting
Study contacts
- Principal investigator: Tahmeed Ahmed, PhD — International Centre for Diarrhoeal Disease Research, Bangladesh
- Study coordinator: Monira Sarmin, MBBS, MCPS
- Email: drmonira@icddrb.org
- Phone: +8801718596947
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.