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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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
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
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
Time frame: From time of randomization until 28 days, if death occurs, time is set to 0 days
Recuitment rates
Secondary feasibility outcome 1
Time frame: 12 months
Proportion of eligible randomised
Other feasibility 2
Time frame: 12 months
Proportion of eligible consented using perspective consent and consent to continue
Other feasibility 3
Time frame: 12 months
Time to initiation of inotropes between the control and the early inotrope arm
Other feasibility 4
Time frame: 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
Time frame: 24 hours
Protocol violations
Other feasibility 6. Percentage of patients not treated according to the assigned group.
Time frame: 12 months
Survival free of inotrope support at 7 days
Secondary exploratory clinical outcome 1
Time frame: 7 days
Survival free of invasive ventilation support at 7 days
Secondary exploratory clinical outcome 2
Time frame: 7 days
28-day mortality
Secondary exploratory clinical outcome 3
Time frame: From time of randomization until 28 days
Survival free of PICU censored at 28 days
Secondary exploratory clinical outcome 4
Time frame: 28 days
PICU length of stay
Secondary exploratory clinical outcome 5
Time frame: 28 days
Hospital length of stay
Secondary exploratory clinical outcome 6
Time frame: 28 days
Functional Status Score at 28 days
Secondary exploratory clinical outcome 7
Time frame: 28 days
Modified Pediatric Overall Performance Category at 28 days
Secondary exploratory clinical outcome 7
Time frame: 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
Time frame: 24 hours
Proportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment
Secondary exploratory clinical outcome 9
Time frame: 24 hours
Time to reversal of tachycardia during the first 24 h
Secondary exploratory clinical outcome 10
Time frame: 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
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.