Septic Shock
Conditions
Keywords
Pediatric Septic Shock, Fluid-Refractory Septic Shock;, Hypotensive Septic Shock, Pediatric Sepsis, Dopamine, Epinephrine
Brief summary
This randomized clinical trial was conducted to compare dopamine with epinephrine as the first vasoactive treatment in children aged 2 to 12 years with fluid-refractory hypotensive septic shock. Children who remained hypotensive with signs of poor tissue perfusion after receiving standardized intravenous fluid resuscitation were enrolled and randomly assigned in a 1:1 ratio to receive either dopamine or epinephrine. The study was designed to determine whether epinephrine resulted in a higher rate of shock reversal within the first 60 minutes after starting vasoactive treatment compared with dopamine. Shock reversal was assessed using improvement in age-appropriate blood pressure, capillary refill, peripheral circulation, mental status, and urine output. A total of 66 children were included, with 33 participants assigned to each treatment group. Epinephrine was administered at doses ranging from 0.1 to 0.3 microgram/kg/minute, while dopamine was administered at doses ranging from 10 to 20 microgram/kg/minute according to a predefined escalation schedule. In addition to shock reversal within one hour, the study compared sustained hemodynamic stability, the requirement for invasive mechanical ventilation within 24 hours, and in-hospital mortality between the two treatment groups.
Interventions
DRUGEpinephrine
Epinephrine infusion was initiated at 0.1 microgram/kg/minute through peripheral, intraosseous, or central vascular access. If shock reversal criteria were not achieved, the dose was increased to 0.2 microgram/kg/minute at 15 minutes and to 0.3 microgram/kg/minute at 30 minutes. The maximum study dose during the first-hour assessment period was 0.3 microgram/kg/minute.
DRUGdopamine
Dopamine infusion was initiated at 10 microgram/kg/minute through peripheral, intraosseous, or central vascular access. If shock reversal criteria were not achieved, the dose was increased to 15 microgram/kg/minute at 15 minutes and to 20 microgram/kg/minute at 30 minutes. The maximum study dose during the first-hour assessment period was 20 microgram/kg/minute.
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 2 to 12 years, of either sex, presenting to the Pediatric Emergency Department or Pediatric Intensive Care Unit. * Suspected or proven infection, supported by a documented clinical focus of infection or microbiological evidence. * Fluid-refractory hypotensive septic shock .
Exclusion criteria
* Shock not meeting the operational definition of fluid-refractory hypotensive septic shock after standardized fluid resuscitation. * Receipt of any vasoactive infusion, including dopamine, epinephrine, norepinephrine, vasopressin, dobutamine, or equivalent, before eligibility confirmation and randomization. * Known cyanotic congenital heart disease, significant structural heart disease with hemodynamic compromise, or documented cardiomyopathy. * Primary arrhythmic instability requiring antiarrhythmic therapy at presentation. * Anaphylaxis, acute hemorrhage, major trauma, or obstructive shock, such as tension pneumothorax or cardiac tamponade, as the primary cause of hypotension. * Clinical indication for an alternative initial vasoactive strategy mandated by the treating team at screening, including predominant warm vasodilatory shock requiring norepinephrine as first-line therapy. * Documented limitation of care orders, including do-not-resuscitate status, or anticipated withdrawal of life-sustaining therapy at presentation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shock Reversal Within 60 Minutes | 60 minutes after initiation of the randomized vasoactive infusion | Shock reversal was defined as achievement of all prespecified criteria simultaneously: systolic blood pressure at or above the age-specific threshold, capillary refill time ≤2 seconds, warm extremities with palpable peripheral pulses, mental status improved to Alert on the AVPU scale, and urine output ≥1 mL/kg/hour during the first hour after initiation of the randomized vasoactive infusion. The outcome was recorded as achieved or not achieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Hemodynamic Stability Following Shock Reversal | 120 minutes after the first documented shock reversal | Sustained hemodynamic stability was defined as continuous maintenance of the shock reversal criteria for at least 120 minutes after the first documented shock reversal, without addition of a second vasoactive infusion, increase in the vasoactive dose above the dose at which shock reversal was achieved, or recurrence of hypotension below the age-specific systolic blood pressure threshold. The outcome was recorded as achieved or not achieved. |
| Requirement for Invasive Mechanical Ventilation Within 24 Hours | within 24 hours | Requirement for invasive mechanical ventilation was defined as endotracheal intubation followed by initiation of positive-pressure mechanical ventilation during the prespecified observation period. The outcome was recorded as occurred or not occurred. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMaryam Sana
Nishtar Hospital Multan
Outcome results
None listed