Early Resuscitation in Paediatric Sepsis Using Inotropes

NCT ID: NCT06478797

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Fluid

Intervention Type: 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.

Intervention group

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

Group Type: EXPERIMENTAL

Adrenalin

Intervention Type: 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

Interventions

Fluid

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.

Intervention Type: OTHER

Adrenalin

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 Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 28 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: collaborator

Universidad Nacional del Nordeste, Argentina

OTHER

Sponsor Role: collaborator

Instituto Latino Americano de Sepse

UNKNOWN

Sponsor Role: collaborator

Hospital Pablo Tobón Uribe

OTHER

Sponsor Role: collaborator

NATALIA LOPERA MUNERA

OTHER

Sponsor Role: lead

Responsible Party

NATALIA LOPERA MUNERA

Pediatrician, principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital de Niños "Dr. Orlando Alassia"

Santa Fe, , Argentina

Hospital Regional San Juan De Dios Tarija

Tarija, , Bolivia

Hospital De Clínicas

Asunción, , Paraguay

Hospital Niños de Acosta Ñu

San Lorenzo, , Paraguay

Countries

Argentina; Bolivia; Paraguay

Central Contacts

Natalia Lopera, MD

Role: CONTACT

natalialoperam@gmail.com

+57 3122978381

Facility Contacts

Rodolfo Pacce, MD

Role: primary

rodolfopacce2000@yahoo.com.ar

+54 9 3424350350

Nils Casson, MD

Role: primary

nilsjefe1@hotmail.com

+591 7 6187393

Ricardo Iramain, MD

Role: primary

iramainricardo@gmail.com

+595 981300491

Viviana Pavlicich, MD

Role: primary

p_viviana@hotmail.com

+595 971206043

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Other Identifiers

IRB: 00006311

Identifier Type: -

Identifier Source: org_study_id