Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock

NCT07775001 | Active Not Recruiting

• 1 other identifier: NMU2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Pediatric Septic Shock; Fluid-Refractory Septic Shock;; Hypotensive Septic Shock; Pediatric Sepsis; Dopamine; Epinephrine

Outcome Measures

Primary Outcomes (1)

• Shock Reversal Within 60 Minutes

  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.

  60 minutes after initiation of the randomized vasoactive infusion

Secondary Outcomes (2)

• Sustained Hemodynamic Stability Following Shock Reversal

  120 minutes after the first documented shock reversal

• Requirement for Invasive Mechanical Ventilation Within 24 Hours

  within 24 hours

Study Arms (2)

Epinephrine Group

EXPERIMENTAL

Participants received epinephrine as the first-line vasoactive agent for fluid-refractory hypotensive septic shock. Epinephrine was initiated at 0.1 microgram/kg/minute and increased according to the predefined protocol if shock reversal was not achieved. All participants also received standard sepsis management according to institutional practice.

Drug: Epinephrine

Dopamine Group

ACTIVE COMPARATOR

Participants received dopamine as the first-line vasoactive agent for fluid-refractory hypotensive septic shock. Dopamine was initiated at 10 microgram/kg/minute and increased according to the predefined protocol if shock reversal was not achieved. All participants also received standard sepsis management according to institutional practice.

Drug: dopamine

Interventions

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.

Epinephrine Group

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.

Dopamine Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Hospital Multan

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Epinephrine; Dopamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Maryam Sana

  Nishtar Hospital Multan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 19, 2026
• Study Start: February 18, 2026
• Primary Completion: September 17, 2026
• Study Completion: September 17, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

PA (1)