Early Resuscitation in Paediatric Sepsis Using Inotropes

Phase 2

Not yet recruiting

• Conditions: Sepsis
• Interventions: Other: Fluid; Drug: Adrenalin

• Registration Number: NCT06478797
• Lead Sponsor: NATALIA LOPERA MUNERA

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27
• Study Start: 2024-07
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Fluid	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
Intervention group	Adrenalin	Sepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg

Primary Outcome Measures

Name	Time	Method
Survival free of organ support at 28 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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