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ACTIVE NOT RECRUITING
NCT07775001
NA

Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock

Sponsor: Nishtar Medical University

View on ClinicalTrials.gov

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.

Official title: Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

2 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-02-18

Completion Date

2026-09-17

Last Updated

2026-08-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

Epinephrine

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.

DRUG

dopamine

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.

Locations (1)

Nishtar Hospital Multan

Multan, Punjab Province, Pakistan