Management of Shock in Children With SAM and Diarrhea

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: Muhimbili University of Health and Allied Sciences; University of British Columbia
• Treatments: Dopamine; Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

1. Children of either sex with SAM and diarrhea

2. Age: 1-59 months

3. Fluid refractory shock

Exclusion Criteria:

1. Severe anemia (hemoglobin< 5 gm/dl) who will require a blood transfusion

2. Sclerema

3. Congenital anomalies (TOF/ASD/VSD/Trisomy 21, etc.)

4. Developmental delay (H/O perinatal asphyxia/cerebral palsy)

5. Having a rare blood group