Early Resuscitation in Paediatric Sepsis Using Inotropes (ANDES-CHILD)

June 24, 2024 updated by: NATALIA LOPERA MUNERA

Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Santa Fe, Argentina
        • Hospital de Niños "Dr. Orlando Alassia"
        • Contact:
        • Principal Investigator:
          • Rodolfo Pacce, MD
  • Bolivia
      • Tarija, Bolivia
        • Hospital Regional San Juan De Dios Tarija
        • Contact:
        • Principal Investigator:
          • Nils Casson, MD
  • Paraguay
      • Asunción, Paraguay
        • Hospital de Clínicas
        • Contact:
        • Principal Investigator:
          • Ricardo Iramain, MD
      • San Lorenzo, Paraguay
        • Hospital Niños de Acosta Ñu
        • Contact:
        • Principal Investigator:
          • Viviana Pavlicich, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Other: 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.
Experimental: Intervention group
Sepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival free of organ support at 28 days
Time Frame: From time of randomization until 28 days, if death occurs, time is set to 0 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recuitment rates
Time Frame: 12 months
Secondary feasibility outcome 1
12 months
Proportion of eligible randomised
Time Frame: 12 months
Other feasibility 2
12 months
Proportion of eligible consented using perspective consent and consent to continue
Time Frame: 12 months
Other feasibility 3
12 months
Time to initiation of inotropes between the control and the early inotrope arm
Time Frame: 24 hours
Other feasibility 4
24 hours
Amount of fluid delivered (in mLs per kg) during the first 24 h between the control and the early inotrope arm
Time Frame: 24 hours
Other feasibility 5
24 hours
Protocol violations
Time Frame: 12 months
Other feasibility 6. Percentage of patients not treated according to the assigned group.
12 months
Survival free of inotrope support at 7 days
Time Frame: 7 days
Secondary exploratory clinical outcome 1
7 days
Survival free of invasive ventilation support at 7 days
Time Frame: 7 days
Secondary exploratory clinical outcome 2
7 days
28-day mortality
Time Frame: From time of randomization until 28 days
Secondary exploratory clinical outcome 3
From time of randomization until 28 days
Survival free of PICU censored at 28 days
Time Frame: 28 days
Secondary exploratory clinical outcome 4
28 days
PICU length of stay
Time Frame: 28 days
Secondary exploratory clinical outcome 5
28 days
Hospital length of stay
Time Frame: 28 days
Secondary exploratory clinical outcome 6
28 days
Functional Status Score at 28 days
Time Frame: 28 days
Secondary exploratory clinical outcome 7
28 days
Modified Pediatric Overall Performance Category at 28 days
Time Frame: 28 days
Secondary exploratory clinical outcome 7
28 days
Amount of fluid (mLs per kg) received during the first hour, and by 4, 12, and 24 hour post enrolment
Time Frame: 24 hours
Secondary exploratory clinical outcome 8
24 hours
Proportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment
Time Frame: 24 hours
Secondary exploratory clinical outcome 9
24 hours
Time to reversal of tachycardia during the first 24 h
Time Frame: 24 hours
Secondary exploratory clinical outcome 10
24 hours
Time to shock reversal, defined as cessation of inotropes for at least 4 h censored at 28 days
Time Frame: 28 days
Secondary exploratory clinical outcome 11
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NATALIA LOPERA MUNERA

Collaborators

University Children's Hospital, Zurich
Hospital Pablo Tobón Uribe
Universidad Nacional del Nordeste, Argentina
Instituto Latino Americano de Sepse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB: 00006311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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