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Active Not Recruiting NCT07775001

Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock

Conditions: Septic Shock

Sex: All
Ages: 2 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 66
Sponsor: Nishtar Medical University

Location: Nishtar Hospital Multan Multan Punjab Province

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.

Eligibility Criteria

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.

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Source: ClinicalTrials.gov (NCT07775001). StuddyBuddy aggregates publicly available trial information.