A Phase 3 interventional study of Blood and Dopamine and Blood and adrenaline in Shock Hypovolemic, Shock, Septic and Blood Transfusion, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Recruiting at 1 site in Bangladesh. Open to participants aged 1 Month to 59 Months. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 3, Interventional, and Treatment
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.
Background:
Hypothesis: We hypothesize that the death rates will be significantly lower in children with SAM or severe underweight, dehydrating diarrhea and fluid refractory shock who will be treated with blood transfusion and adrenaline compared to blood transfusion and dopamine, after treatment failure with WHO standard bolus intravenous fluid therapy.
Objectives: To reduce mortality of the SAM or severely underweight children presenting with diarrhea and fluid refractory shock who will receive WHO standard fluid therapy followed by blood transfusion with either dopamine or adrenaline.
Methods: This will be a randomized, two-arm, controlled, non-masked clinical trial in children 1- 59 months old with SAM or severely underweight and fluid refractory shock. It will compare the efficacy of WHO-recommended fluid resuscitation followed by blood transfusion and dopamine versus blood transfusion and adrenaline. Children in both groups will also receive inj hydrocortisone. After parental written informed consent, children, in addition to usual supportive care, will be allocated to the study interventions following randomization.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 135 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 206 studies on the registry; 31 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Shock. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children in this group (Treatment plan A) will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. In addition, they will receive dopamine, 8 microgram/kg/min (increasing the dose after 15 minutes to 12 microgram/kg/min to a maximum of 15 microgram/kg/min)
Drug: Blood and Dopamine
Children in this group (Treatment plan B) will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. In addition, they will receive adrenaline, 0.1 microgram/kg/min (increasing the dose after 15 minutes to 0.2 microgram/kg.min to a maximum of 0.3 microgram/kg.min)
Drug: Blood and adrenaline
Drug pages: Whole blood · Dopamine
Children in this group will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. They will also receive dopamine, 8 microgram/kg.min (increasing the dose after 15 minutes to 12 microgram/kg/min to a maximum of 15 microgram/kg/min)
Also known as: Dopamine, Blood
Drug pages: Whole blood · Epinephrine
Children in this group will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. They will also receive adrenaline, 0.1 microgram/kg/min (increasing the dose after 15 minutes to 0.2 microgram/kg.min to a maximum of 0.3 microgram/kg.min)
Also known as: Epinephrine, Blood
Case fatality rate
Number of mortalities among acutely malnourished children presenting with diarrhea and fluid refractory shock who would receive WHO standard fluid therapy followed by blood transfusion with either dopamine or adrenaline.
Time frame: 28 days (± 3 days)
Treatment failure rates
Number of children where we failed to achieve the goal of resuscitation after starting any one of the interventions
Time frame: Through study completion, an average of 7 days
Need for mechanical ventilation
Number of children who would require mechanical ventilation
Time frame: Through study completion, an average of 7 days
Heart failure
Number of children who developed heart failure. Heart failure will be assessed on the basis of - age-specific tachypnea, tachycardia, enlarged tender liver, pedal edema, basal crackles and/or gallop and response to furosemide (combination of findings).
Time frame: Through study completion, an average of 7 days
Length of ICU stay
Time a child stays in ICU
Time frame: Through study completion, an average of 7 days
Time-to-achieve recovery
Required times (minutes) for resuscitation of a child after randomization to a specific arms
Time frame: 3-4 hours
Left ventricular function of the study participants
Evaluation of left ventricular function (hyperdynamic or normal) by cardiac USG at enrollment, at time of heart failure (if any)
Time frame: Through study completion, an average of 7 days
Right ventricular function of the study participants
Evaluation of right ventricular function (hyperdynamic or normal) by cardiac ultrasound at enrollment, at time of heart failure (if any)
Time frame: Through study completion, an average of 7 days
Inferior vena cava collapsibility of the study participants
Evaluation of Inferior vena cava collapsibility by cardiac ultrasound at enrollment, at time of heart failure (if any)
Time frame: Through study completion, an average of 7 days
Length of hospital stay
Time a child stays in the hospital
Time frame: variable (days to months)
Mean arterial pressure (MAP) stabilization at 48 hours
Number of children whose MAP was stabilized at 48 hours
Time frame: 48 hours from the point of inclusion in the study
Plan to share: No
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Studies of the drugs tested here: Whole blood · Epinephrine
International Centre for Diarrhoeal Disease Research, Bangladesh →