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NCT Number: NCT07775001

Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Hospital Multan

Multan, Punjab Province, 66000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epinephrine

Drug

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.

Dopamine

Drug

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.

Primary outcomes

  1. Shock Reversal Within 60 Minutes

    Time frame: 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 outcomes

  1. Sustained Hemodynamic Stability Following Shock Reversal

    Time frame: 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.

  2. Requirement for Invasive Mechanical Ventilation Within 24 Hours

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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