Early Resuscitation in Paediatric Sepsis Using Inotropes
NCT Number: NCT06478797
Acronym: ANDES-CHILD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Sepsis
Interventions: OTHER: Fluid|DRUG: Adrenalin
Sponsor: NATALIA LOPERA MUNERA
Collaborators: University Children's Hospital, Zurich|Universidad Nacional del Nordeste, Argentina|Instituto Latino Americano de Sepse|Hospital Pablo Tobón Uribe
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-12
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

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)

Primary Outcome Measures: 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 Outcome Measures: Recuitment rates, Secondary feasibility outcome 1, 12 months|Proportion of eligible randomised, Other feasibility 2, 12 months|Proportion of eligible consented using perspective consent and consent to continue, Other feasibility 3, 12 months|Time to initiation of inotropes between the control and the early inotrope arm, 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, Other feasibility 5, 24 hours|Protocol violations, Other feasibility 6. Percentage of patients not treated according to the assigned group., 12 months|Survival free of inotrope support at 7 days, Secondary exploratory clinical outcome 1, 7 days|Survival free of invasive ventilation support at 7 days, Secondary exploratory clinical outcome 2, 7 days|28-day mortality, Secondary exploratory clinical outcome 3, From time of randomization until 28 days|Survival free of PICU censored at 28 days, Secondary exploratory clinical outcome 4, 28 days|PICU length of stay, Secondary exploratory clinical outcome 5, 28 days|Hospital length of stay, Secondary exploratory clinical outcome 6, 28 days|Functional Status Score at 28 days, Secondary exploratory clinical outcome 7, 28 days|Modified Pediatric Overall Performance Category at 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, Secondary exploratory clinical outcome 8, 24 hours|Proportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment, Secondary exploratory clinical outcome 9, 24 hours|Time to reversal of tachycardia during the first 24 h, 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, Secondary exploratory clinical outcome 11, 28 days