A Phase 2 interventional study of Fluid and Adrenalin in Sepsis, sponsored by NATALIA LOPERA MUNERA. Not yet recruiting at 4 sites in 3 countries. Open to participants aged 28 Days to 18 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by NATALIA LOPERA MUNERA · Phase 2, Interventional, and Treatment
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)
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 40 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →This is the only study on the registry with NATALIA LOPERA MUNERA as lead sponsor.
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Exclusion Criteria:
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 early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg
Drug: Adrenalin
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
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
Plan to share: No
Start is estimated for Jul 2024; primary completion for Jul 2025, 12 months later.
Of 43 non-industry phase 2 interventional studies under Sepsis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 35. This study's planned 12 months is below that.
Counting every sponsor, half of 60 studies reached it within 29 months; a quarter within 17 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epinephrine