Managing shock in malnourished children with diarrhea
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
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 |
| Enrollment | 135 (estimated) |
| Ages | 1 Month to 59 Months |
| Sex | All |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT04750070 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-59 months with acute malnutrition and diarrhea who are experiencing fluid refractory shock.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dhaka
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.