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

NCT04750070 | Recruiting Phase 3 DMC

• 1 other identifier: PR-20021
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock Hypovolemic; Shock, Septic; Blood Transfusion; Adrenaline; Dopamine

Keywords

Severe acute malnutrition; Children; Shock; Cholera; Dehydrating diarrhea; Severe underweight; Acute malnutrition

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days (± 3 days)

Secondary Outcomes (10)

• Treatment failure rates

  Through study completion, an average of 7 days

• Need for mechanical ventilation

  Through study completion, an average of 7 days

• Heart failure

  Through study completion, an average of 7 days

• Length of ICU stay

  Through study completion, an average of 7 days

• Time-to-achieve recovery

  3-4 hours

Study Arms (2)

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)

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)

Drug: Blood and adrenaline

Interventions

Blood and Dopamine DRUG

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

Blood Transfusion and Dopamine arm

Blood and adrenaline DRUG

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

Blood Transfusion and Adrenaline arm

Eligibility Criteria

• Age: 1 Month - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of British Columbia: collaborator
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Icddr,B

Dhaka, 1000, Bangladesh

RECRUITING

Related Publications (24)

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  BACKGROUND

• Sarmin M, Shaly NJ, Sultana T, Tariqujjaman M, Shikha SS, Mariam N, Jeorge DH, Tabassum M, Nahar B, Afroze F, Shahrin L, Hossain MI, Alam B, Faruque ASG, Islam MM, Osmany DMF, Ahmed CM, Manji K, Kissoon N, Chisti MJ, Ahmed T. Efficacy of dopamine, epinephrine and blood transfusion for treatment of fluid refractory shock in children with severe acute malnutrition or severe underweight and cholera or other dehydrating diarrhoeas: protocol for a randomised controlled clinical trial. BMJ Open. 2023 Apr 12;13(4):e068660. doi: 10.1136/bmjopen-2022-068660.

  PMID: 37045565 DERIVED

MeSH Terms

Conditions

Shock; Shock, Septic; Severe Acute Malnutrition; Cholera; Thinness

Interventions

Blood Specimen Collection; Dopamine; Epinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols

Study Officials

• Tahmeed Ahmed, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monira Sarmin, MBBS, MCPS

CONTACT

+8801718596947; drmonira@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 11, 2021
• Study Start: August 17, 2021
• Primary Completion: July 31, 2025
• Study Completion: November 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)