Sepsis
Conditions
Keywords
pediatric sepsis, septic shock, inotropes, adrenaline, emergency department, fluid, child
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)
Interventions
OTHERFluid
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.
DRUGAdrenalin
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
Sponsors
NATALIA LOPERA MUNERA
University Children's Hospital, Zurich
Universidad Nacional del Nordeste, Argentina
Instituto Latino Americano de Sepse
Hospital Pablo Tobón Uribe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a two-armed control study. One of the arms is the control group, so a group of participants, that is being treated with the standard therapy. The other arm is the intervention group, a group of participants that is being treated with adrenaline. It will be random which child is assigned to which group, this insures that the study is not biased.
Eligibility
Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Recuitment rates | 12 months | Secondary feasibility outcome 1 |
| 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 |
| Time to initiation of inotropes between the control and the early inotrope arm | 24 hours | Other feasibility 4 |
| Protocol violations | 12 months | Other feasibility 6. Percentage of patients not treated according to the assigned group. |
| Survival free of inotrope support at 7 days | 7 days | Secondary exploratory clinical outcome 1 |
| Survival free of invasive ventilation support at 7 days | 7 days | Secondary exploratory clinical outcome 2 |
| 28-day mortality | From time of randomization until 28 days | Secondary exploratory clinical outcome 3 |
| 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 |
| PICU length of stay | 28 days | Secondary exploratory clinical outcome 5 |
| Hospital length of stay | 28 days | Secondary exploratory clinical outcome 6 |
| Functional Status Score at 28 days | 28 days | Secondary exploratory clinical outcome 7 |
| 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 |
| Proportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment | 24 hours | Secondary exploratory clinical outcome 9 |
| Time to reversal of tachycardia during the first 24 h | 24 hours | Secondary exploratory clinical outcome 10 |
| 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 |
| Survival free of PICU censored at 28 days | 28 days | Secondary exploratory clinical outcome 4 |
Countries
Argentina, Bolivia, Paraguay
Contacts
Primary ContactNatalia Lopera, MD
Outcome results
None listed