Early Resuscitation in Paediatric Sepsis Using Inotropes

NCT06478797 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IRB: 00006311
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 4

Brief Summary

Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)

Conditions

Sepsis

Keywords

pediatric sepsis; septic shock; inotropes; adrenaline; emergency department; fluid; child

Outcome Measures

Primary Outcomes (1)

• Survival free of organ support at 28 days

  Organ support will be defined as invasive ventilation support, cardiovascular organ support (inotropic or ECMO support), and renal replacement therapy

  From time of randomization until 28 days, if death occurs, time is set to 0 days

Secondary Outcomes (18)

• Recuitment rates

  12 months

• Proportion of eligible randomised

  12 months

• Proportion of eligible consented using perspective consent and consent to continue

  12 months

• Time to initiation of inotropes between the control and the early inotrope arm

  24 hours

• Amount of fluid delivered (in mLs per kg) during the first 24 h between the control and the early inotrope arm

  24 hours

Study Arms (2)

Control group

ACTIVE COMPARATOR

Sepsis will be treated with a standardized therapy protocol, where participants will receive fluids for resuscitation. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes

Other: Fluid

Intervention group

EXPERIMENTAL

Sepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg

Drug: Adrenalin

Interventions

Fluid OTHER

Sepsis will be treated with standardized therapy protocol, where participants receive fluids (balanced or non-balanced crystalloids, or colloids) to be resuscitated. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes.

Control group

Adrenalin DRUG

Sepsis will be treated with early inotropes, where participants will receive adrenaline at a dose of 0.05 - 0.1 mcg/kg/min via peripheral intravenous, intraosseous, or central venous routes after the first fluid bolus of 20 ml/kg

Intervention group

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• days and \<18 years
• Treated for sepsis
• Received at least 20 ml/kg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock
• Parental/caregiver consent prior to or after enrolment

You may not qualify if:

• Preterm babies born \<34 weeks gestation that have a corrected age of \<28 days
• Received ≥ 40 mL/kg of fluid boluses during the 4 h pre-enrolment
• Inotrope infusion commenced pre-enrolment
• Lack of access (intraosseous, central venous or peripheral) to administer fluids and/or inotropes after 60min of enrolment
• Cardiomyopathy or chronic cardiac failure
• Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment
• Known chronic renal failure (defined as requiring renal replacement therapy)
• Known chronic hepatic failure
• Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)
• Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of \>2min duration, or death is deemed to be imminent or inevitable during this admission.
• Major bleeding with haemorrhagic shock
• Sepsis is not likely to be the cause of shock
• Previous enrollment in ANDES-CHILD

Sponsors & Collaborators

• NATALIA LOPERA MUNERA: lead
• University Children's Hospital, Zurich: collaborator
• Universidad Nacional del Nordeste, Argentina: collaborator
• Instituto Latino Americano de Sepse: collaborator
• Hospital Pablo Tobón Uribe: collaborator

Study Sites (4)

Hospital de Niños "Dr. Orlando Alassia"

Santa Fe, Argentina

Location

Hospital Regional San Juan De Dios Tarija

Tarija, Bolivia

Location

Hospital De Clínicas

Asunción, Paraguay

Location

Hospital Niños de Acosta Ñu

San Lorenzo, Paraguay

Location

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MeSH Terms

Conditions

Sepsis; Shock, Septic; Emergencies

Interventions

Fluid Therapy; Epinephrine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Natalia Lopera, MD

CONTACT

+57 3122978381; natalialoperam@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatrician, principal investigator

Model Details: The study is a two-armed control study. One of the arms is the control group, so a group of participants, that is being treated with the standard therapy. The other arm is the intervention group, a group of participants that is being treated with adrenaline. It will be random which child is assigned to which group, this insures that the study is not biased.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 27, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2); AR (1); BO (1)