Septic ShockNCT07775001
Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock
A study testing Epinephrine and dopamine in people with Septic Shock, run by Nishtar Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Epinephrine and dopamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Feb 2026to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock: A Randomized Clinical Trial
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
- Being tested
- Epinephrine, dopamine
- Keywords
- Pediatric Septic Shock, Fluid-Refractory Septic Shock;, Hypotensive Septic Shock, Pediatric Sepsis, Dopamine, Epinephrine
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
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.
dopamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes after initiation of the randomized vasoactive infusion
Secondary outcomes (2)
Sustained Hemodynamic Stability Following 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.
Measured: 120 minutes after the first documented shock reversal
Requirement for Invasive Mechanical Ventilation 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.
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start18 Feb 2026
- Primary completion17 Sep 2026 (estimated)
- Study completion17 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazia Parveen, Nishtar Medical University
- Investigators
- Maryam Sana, Principal investigator, Nishtar Hospital Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775001
- Sponsor's protocol ID
- NMU2
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07775001
- Acronym / sponsor ID
- NMU2
- Conditions
- Septic Shock
- Keywords
- Pediatric Septic Shock, Fluid-Refractory Septic Shock;, Hypotensive Septic Shock, Pediatric Sepsis, Dopamine, Epinephrine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 17 Sep 2026 (estimated)
- Study completion
- 17 Sep 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine Group | Experimental | Drug: EpinephrineParticipants 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. |
| Dopamine Group | Active comparator | Drug: dopamineParticipants 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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpinephrineEpinephrine 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 | Epinephrine Group |
| dopamineDopamine 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. | Drug | Dopamine Group |
Primary outcome
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.
2 secondary outcomes
Sustained Hemodynamic Stability Following Shock Reversal
Time frame: 120 minutes after the first documented shock reversal
Requirement for Invasive Mechanical Ventilation Within 24 Hours
Time frame: within 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Sana principal investigator
Nishtar Hospital Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine and dopamine in people with Septic Shock, run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shock Reversal Within 60 Minutes (time frame: 60 minutes after initiation of the randomized vasoactive infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.