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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 16, 2025 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Feb 2023 to Jul 31, 2025v7 Show 5 more changesShow less
    • Study completion date: Apr 2023 to Nov 30, 2025
    • Interventions: Blood Transfusion (Drug), Dopamine (Drug), adrenaline (Drug) to Blood and Dopamine (Drug), Blood and adrenaline (Drug)
    • Study arms: 3 to 2
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 1 word
  2. Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 8 to 10
    • Study description expanded, about 9 words
    • Study title expanded, about 3 words
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2021 to Aug 17, 2021
    • Site details revised
    v4
  5. Start date: Jul 2021 to Oct 2021v3
  6. Start date: Mar 2021 to Jul 2021v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04750070
Lead Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: University of British Columbia, Muhimbili University of Health and Allied Sciences
Conditions
(from sponsor)		 Shock Hypovolemic, Shock, Septic, Blood Transfusion, Adrenaline, Dopamine
Related terms Cholera, Severe Acute Malnutrition, Shock, Shock, Septic, Thinness
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov