Shock HypovolemicPhase 3NCT04750070
Management of Shock in Children With SAM or Severe Underweight and Diarrhea
A Phase 3 study testing Blood and Dopamine and Blood and adrenaline in people with Shock Hypovolemic and Shock, Septic, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Shock Hypovolemic, Shock, Septic, Blood Transfusion
- What is being tested?
- Blood and Dopamine and Blood and adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteBangladesh
- Study dates
- 17 Aug 2021to 30 Nov 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either sex with acute malnutrition and diarrhea
- Age: 1-59 months
- Children with cerebral palsy (CP) and/or developmental delay, Down Syndrome with or without heart diseases
- Fluid refractory shock
- Consent from the caregivers/parents
Who cannot join
- Having a rare blood group (Rh negative blood groups provided that donor is not available)
- A child requiring cardio-pulmonary resuscitation during screening or having gasping respiration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Icddr,B
Dhaka, 1000
Monira Sarmin, MCPS, drmonira@icddrb.org
Tahmeed Ahmed, PhD
About this study
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
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.
Read the detailed description
Background:
- Burden: Burden: Diarrhea is one of the leading causes of under-five childhood mortality and accounts for 8% of 5.4 million global under-5 deaths. Co-morbidity of severe acute malnutrition (SAM) and shock in children with diarrhea is associated with increased mortality. Nearly half of the patients admitted to the Intensive Care Unit (ICU) of Dhaka Hospital of icddr,b present with sepsis. Data demonstrates that about 43% of children progressed from severe sepsis to septic shock despite receiving recommended treatment. The death rate was found to be as high as 40% and 69% in children with severe sepsis and septic shock respectively with co-morbidities such as severe malnutrition.
- Knowledge gap: The conventional management of SAM children with features of severe sepsis recommended by WHO include administration of boluses of isotonic saline followed by blood transfusion in unresponsive cases with septic shock. However, a recent African study reported significantly higher mortality among children with features of severe sepsis when they were treated with boluses. To date, no study has evaluated systematically the effects of inotrope or vasopressor or blood transfusion in children with dehydrating diarrhea (for example, in cholera) and SAM having shock and unresponsive to WHO standard fluid therapy.
- Relevance: If this randomized trial signifies survival benefit from a blood transfusion, inotrope or vasopressor in the management of fluid refractory shock in children with severe acute malnutrition and cholera or other dehydrating diarrheas, then this approach would be a good candidate for implementation in the management of such children especially in developing countries
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.
- Conditions
- Shock Hypovolemic, Shock, Septic, Blood Transfusion, Adrenaline, Dopamine
- Being tested
- Blood and Dopamine, Blood and adrenaline
- Keywords
- Severe acute malnutrition, Children, Shock, Cholera, Dehydrating diarrhea, Severe underweight, Acute malnutrition
- Medical subject headings
- Shock, Shock, Septic, Severe Acute Malnutrition, Cholera, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and DopamineDrug
Also called Dopamine, Blood
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)
Blood and adrenalineDrug
Also called Epinephrine, Blood
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)
| Study group | Role | What they receive |
|---|---|---|
| Blood Transfusion and Dopamine arm | Active comparator | 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) Receives: Drug: Blood and Dopamine |
| Blood Transfusion and Adrenaline arm | Experimental | 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) Receives: Drug: Blood and adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days (± 3 days)
Secondary outcomes (10)
Treatment failure rates
Number of children where we failed to achieve the goal of resuscitation after starting any one of the interventions
Measured: Through study completion, an average of 7 days
Need for mechanical ventilation
Number of children who would require mechanical ventilation
Measured: 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).
Measured: Through study completion, an average of 7 days
Length of ICU stay
Time a child stays in ICU
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Through study completion, an average of 7 days
Length of hospital stay
Time a child stays in the hospital
Measured: variable (days to months)
Mean arterial pressure (MAP) stabilization at 48 hours
Number of children whose MAP was stabilized at 48 hours
Measured: 48 hours from the point of inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start17 Aug 2021
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Shock HypovolemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Systematic evaluation of the effects of blood transfusion and inotrope(s) and vasopressor in children with dehydrating diarrhea (for example, in cholera) and acute malnutrition having fluid refractory shock and unresponsive to WHO standard fluid therapy
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Tahmeed Ahmed, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750070
- Sponsor's protocol ID
- PR-20021
- Status last verified
- Apr 2025
- First submitted
- 1 Feb 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pocket Book of Hospital Care for Children: Guidelines for the Management of Common Childhood Illnesses. 2nd edition. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK154447/
PubMed 24006557AABB. Technical Manual. 19th ed. Fung MK, Eder AF, Spitalnik SL, Westhoff CM, editors. United States.
Green REB, Klostermann DA. The Antiglobulin Test. In: Harmening D, editor. Modern Blood Banking & Transfusion Practices. 6th ed. Philadelphia: F.A. Davis. p. 107-10.
Chisti MJ, Pietroni MA, Smith JH, Bardhan PK, Salam MA. Predictors of death in under-five children with diarrhoea admitted to a critical care ward in an urban hospital in Bangladesh. Acta Paediatr. 2011 Dec;100(12):e275-9. doi: 10.1111/j.1651-2227.2011.02368.x. Epub 2011 Jun 21.
PubMed 21627690Sarmin M, Ahmed T, Bardhan PK, Chisti MJ. Specialist hospital study shows that septic shock and drowsiness predict mortality in children under five with diarrhoea. Acta Paediatr. 2014 Jul;103(7):e306-11. doi: 10.1111/apa.12640. Epub 2014 Apr 11.
PubMed 24661049Ahmed T, Ali M, Ullah MM, Choudhury IA, Haque ME, Salam MA, Rabbani GH, Suskind RM, Fuchs GJ. Mortality in severely malnourished children with diarrhoea and use of a standardised management protocol. Lancet. 1999 Jun 5;353(9168):1919-22. doi: 10.1016/S0140-6736(98)07499-6.
PubMed 10371570Chisti MJ, Salam MA, Bardhan PK, Faruque AS, Shahid AS, Shahunja KM, Das SK, Hossain MI, Ahmed T. Severe Sepsis in Severely Malnourished Young Bangladeshi Children with Pneumonia: A Retrospective Case Control Study. PLoS One. 2015 Oct 6;10(10):e0139966. doi: 10.1371/journal.pone.0139966. eCollection 2015.
PubMed 26440279Sarker AR, Sultana M, Mahumud RA, Ali N, Huda TM, Salim Uzzaman M, Haider S, Rahman H, Islam Z, Khan JAM, Van Der Meer R, Morton A. Economic costs of hospitalized diarrheal disease in Bangladesh: a societal perspective. Glob Health Res Policy. 2018 Jan 5;3:1. doi: 10.1186/s41256-017-0056-5. eCollection 2018.
PubMed 29318195Guerrant RL, Schorling JB, McAuliffe JF, de Souza MA. Diarrhea as a cause and an effect of malnutrition: diarrhea prevents catch-up growth and malnutrition increases diarrhea frequency and duration. Am J Trop Med Hyg. 1992 Jul;47(1 Pt 2):28-35. doi: 10.4269/ajtmh.1992.47.28.
PubMed 1632474Chisti MJ, Saha S, Roy CN, Salam MA. Predictors of bacteremia in infants with diarrhea and systemic inflammatory response syndrome attending an urban diarrheal treatment center in a developing country. Pediatr Crit Care Med. 2010 Jan;11(1):92-7. doi: 10.1097/PCC.0b013e3181b063e1.
PubMed 19593244Ranjit S, Aram G, Kissoon N, Ali MK, Natraj R, Shresti S, Jayakumar I, Gandhi D. Multimodal monitoring for hemodynamic categorization and management of pediatric septic shock: a pilot observational study*. Pediatr Crit Care Med. 2014 Jan;15(1):e17-26. doi: 10.1097/PCC.0b013e3182a5589c.
PubMed 24196006Davis AL, Carcillo JA, Aneja RK, Deymann AJ, Lin JC, Nguyen TC, Okhuysen-Cawley RS, Relvas MS, Rozenfeld RA, Skippen PW, Stojadinovic BJ, Williams EA, Yeh TS, Balamuth F, Brierley J, de Caen AR, Cheifetz IM, Choong K, Conway E Jr, Cornell T, Doctor A, Dugas MA, Feldman JD, Fitzgerald JC, Flori HR, Fortenberry JD, Graciano AL, Greenwald BM, Hall MW, Han YY, Hernan LJ, Irazuzta JE, Iselin E, van der Jagt EW, Jeffries HE, Kache S, Katyal C, Kissoon N, Kon AA, Kutko MC, MacLaren G, Maul T, Mehta R, Odetola F, Parbuoni K, Paul R, Peters MJ, Ranjit S, Reuter-Rice KE, Schnitzler EJ, Scott HF, Torres A Jr, Weingarten-Arams J, Weiss SL, Zimmerman JJ, Zuckerberg AL. American College of Critical Care Medicine Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock. Crit Care Med. 2017 Jun;45(6):1061-1093. doi: 10.1097/CCM.0000000000002425.
PubMed 28509730Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM; FEAST Trial Group. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011 Jun 30;364(26):2483-95. doi: 10.1056/NEJMoa1101549. Epub 2011 May 26.
PubMed 21615299Seri I, Abbasi S, Wood DC, Gerdes JS. Regional hemodynamic effects of dopamine in the sick preterm neonate. J Pediatr. 1998 Dec;133(6):728-34. doi: 10.1016/s0022-3476(98)70141-6.
PubMed 9842034Maitland K, George EC, Evans JA, Kiguli S, Olupot-Olupot P, Akech SO, Opoka RO, Engoru C, Nyeko R, Mtove G, Reyburn H, Brent B, Nteziyaremye J, Mpoya A, Prevatt N, Dambisya CM, Semakula D, Ddungu A, Okuuny V, Wokulira R, Timbwa M, Otii B, Levin M, Crawley J, Babiker AG, Gibb DM; FEAST trial group. Exploring mechanisms of excess mortality with early fluid resuscitation: insights from the FEAST trial. BMC Med. 2013 Mar 14;11:68. doi: 10.1186/1741-7015-11-68.
PubMed 23496872
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04750070
- Acronym / sponsor ID
- PR-20021
- Conditions
- Shock Hypovolemic, Shock, Septic, Blood Transfusion, Adrenaline, Dopamine
- Keywords
- Severe acute malnutrition, Children, Shock, Cholera, Dehydrating diarrhea, Severe underweight, Acute malnutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of British Columbia, Muhimbili University of Health and Allied Sciences
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Burden: Burden: Diarrhea is one of the leading causes of under-five childhood mortality and accounts for 8% of 5.4 million global under-5 deaths. Co-morbidity of severe acute malnutrition (SAM) and shock in children with diarrhea is associated with increased mortality. Nearly half of the patients admitted to the Intensive Care Unit (ICU) of Dhaka Hospital of icddr,b present with sepsis. Data demonstrates that about 43% of children progressed from severe sepsis to septic shock despite receiving recommended treatment. The death rate was found to be as high as 40% and 69% in children with severe sepsis and septic shock respectively with co-morbidities such as severe malnutrition.
- Knowledge gap: The conventional management of SAM children with features of severe sepsis recommended by WHO include administration of boluses of isotonic saline followed by blood transfusion in unresponsive cases with septic shock. However, a recent African study reported significantly higher mortality among children with features of severe sepsis when they were treated with boluses. To date, no study has evaluated systematically the effects of inotrope or vasopressor or blood transfusion in children with dehydrating diarrhea (for example, in cholera) and SAM having shock and unresponsive to WHO standard fluid therapy.
- Relevance: If this randomized trial signifies survival benefit from a blood transfusion, inotrope or vasopressor in the management of fluid refractory shock in children with severe acute malnutrition and cholera or other dehydrating diarrheas, then this approach would be a good candidate for implementation in the management of such children especially in developing countries
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Systematic evaluation of the effects of blood transfusion and inotrope(s) and vasopressor in children with dehydrating diarrhea (for example, in cholera) and acute malnutrition having fluid refractory shock and unresponsive to WHO standard fluid therapy
| Arm | Type | Receives |
|---|---|---|
| Blood Transfusion and Dopamine arm | Active comparator | Drug: Blood and DopamineChildren 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) |
| Blood Transfusion and Adrenaline arm | Experimental | Drug: Blood and adrenalineChildren 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) |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children of either sex with acute malnutrition and diarrhea
- Age: 1-59 months
- Children with cerebral palsy (CP) and/or developmental delay, Down Syndrome with or without heart diseases
- Fluid refractory shock
- Consent from the caregivers/parents
Key exclusion criteria (2 listed)
- Having a rare blood group (Rh negative blood groups provided that donor is not available)
- A child requiring cardio-pulmonary resuscitation during screening or having gasping respiration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and DopamineAlso: Dopamine, BloodChildren 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) | Drug | Blood Transfusion and Dopamine arm |
| Blood and adrenalineAlso: Epinephrine, BloodChildren 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) | Drug | Blood Transfusion and Adrenaline arm |
Primary outcome
Case fatality rate
Time frame: 28 days (± 3 days)
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.
10 secondary outcomes
Treatment failure rates
Time frame: Through study completion, an average of 7 days
Need for mechanical ventilation
Time frame: Through study completion, an average of 7 days
Heart failure
Time frame: Through study completion, an average of 7 days
Length of ICU stay
Time frame: Through study completion, an average of 7 days
Time-to-achieve recovery
Time frame: 3-4 hours
Left ventricular function of the study participants
Time frame: Through study completion, an average of 7 days
Right ventricular function of the study participants
Time frame: Through study completion, an average of 7 days
Inferior vena cava collapsibility of the study participants
Time frame: Through study completion, an average of 7 days
Length of hospital stay
Time frame: variable (days to months)
Mean arterial pressure (MAP) stabilization at 48 hours
Time frame: 48 hours from the point of inclusion in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 24006557Pocket Book of Hospital Care for Children: Guidelines for the Management of Common Childhood Illnesses. 2nd edition. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK154447/
- BackgroundAABB. Technical Manual. 19th ed. Fung MK, Eder AF, Spitalnik SL, Westhoff CM, editors. United States.
- BackgroundGreen REB, Klostermann DA. The Antiglobulin Test. In: Harmening D, editor. Modern Blood Banking & Transfusion Practices. 6th ed. Philadelphia: F.A. Davis. p. 107-10.
- Results publication: PubMed 21627690Chisti MJ, Pietroni MA, Smith JH, Bardhan PK, Salam MA. Predictors of death in under-five children with diarrhoea admitted to a critical care ward in an urban hospital in Bangladesh. Acta Paediatr. 2011 Dec;100(12):e275-9. doi: 10.1111/j.1651-2227.2011.02368.x. Epub 2011 Jun 21.
- Results publication: PubMed 24661049Sarmin M, Ahmed T, Bardhan PK, Chisti MJ. Specialist hospital study shows that septic shock and drowsiness predict mortality in children under five with diarrhoea. Acta Paediatr. 2014 Jul;103(7):e306-11. doi: 10.1111/apa.12640. Epub 2014 Apr 11.
- Results publication: PubMed 10371570Ahmed T, Ali M, Ullah MM, Choudhury IA, Haque ME, Salam MA, Rabbani GH, Suskind RM, Fuchs GJ. Mortality in severely malnourished children with diarrhoea and use of a standardised management protocol. Lancet. 1999 Jun 5;353(9168):1919-22. doi: 10.1016/S0140-6736(98)07499-6.
- Results publication: PubMed 26440279Chisti MJ, Salam MA, Bardhan PK, Faruque AS, Shahid AS, Shahunja KM, Das SK, Hossain MI, Ahmed T. Severe Sepsis in Severely Malnourished Young Bangladeshi Children with Pneumonia: A Retrospective Case Control Study. PLoS One. 2015 Oct 6;10(10):e0139966. doi: 10.1371/journal.pone.0139966. eCollection 2015.
- Results publication: PubMed 29318195Sarker AR, Sultana M, Mahumud RA, Ali N, Huda TM, Salim Uzzaman M, Haider S, Rahman H, Islam Z, Khan JAM, Van Der Meer R, Morton A. Economic costs of hospitalized diarrheal disease in Bangladesh: a societal perspective. Glob Health Res Policy. 2018 Jan 5;3:1. doi: 10.1186/s41256-017-0056-5. eCollection 2018.
- Results publication: PubMed 1632474Guerrant RL, Schorling JB, McAuliffe JF, de Souza MA. Diarrhea as a cause and an effect of malnutrition: diarrhea prevents catch-up growth and malnutrition increases diarrhea frequency and duration. Am J Trop Med Hyg. 1992 Jul;47(1 Pt 2):28-35. doi: 10.4269/ajtmh.1992.47.28.
- Results publication: PubMed 19593244Chisti MJ, Saha S, Roy CN, Salam MA. Predictors of bacteremia in infants with diarrhea and systemic inflammatory response syndrome attending an urban diarrheal treatment center in a developing country. Pediatr Crit Care Med. 2010 Jan;11(1):92-7. doi: 10.1097/PCC.0b013e3181b063e1.
- Results publication: PubMed 24196006Ranjit S, Aram G, Kissoon N, Ali MK, Natraj R, Shresti S, Jayakumar I, Gandhi D. Multimodal monitoring for hemodynamic categorization and management of pediatric septic shock: a pilot observational study*. Pediatr Crit Care Med. 2014 Jan;15(1):e17-26. doi: 10.1097/PCC.0b013e3182a5589c.
- Results publication: PubMed 28509730Davis AL, Carcillo JA, Aneja RK, Deymann AJ, Lin JC, Nguyen TC, Okhuysen-Cawley RS, Relvas MS, Rozenfeld RA, Skippen PW, Stojadinovic BJ, Williams EA, Yeh TS, Balamuth F, Brierley J, de Caen AR, Cheifetz IM, Choong K, Conway E Jr, Cornell T, Doctor A, Dugas MA, Feldman JD, Fitzgerald JC, Flori HR, Fortenberry JD, Graciano AL, Greenwald BM, Hall MW, Han YY, Hernan LJ, Irazuzta JE, Iselin E, van der Jagt EW, Jeffries HE, Kache S, Katyal C, Kissoon N, Kon AA, Kutko MC, MacLaren G, Maul T, Mehta R, Odetola F, Parbuoni K, Paul R, Peters MJ, Ranjit S, Reuter-Rice KE, Schnitzler EJ, Scott HF, Torres A Jr, Weingarten-Arams J, Weiss SL, Zimmerman JJ, Zuckerberg AL. American College of Critical Care Medicine Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock. Crit Care Med. 2017 Jun;45(6):1061-1093. doi: 10.1097/CCM.0000000000002425.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tahmeed Ahmed, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood and Dopamine and Blood and adrenaline in people with Shock Hypovolemic and Shock, Septic, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monira Sarmin, MBBS, MCPS (+8801718596947 ext. 2186, drmonira@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case fatality rate (time frame: 28 days (± 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750070, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.