An interventional study of Epinephrine and dopamine in Septic Shock, sponsored by Nishtar Medical University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Nishtar Medical University · Not applicable, Interventional, and Treatment
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 66 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
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.
Time frame: 60 minutes after initiation of the randomized vasoactive infusion
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.
Time frame: 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.
Time frame: within 24 hours
Started Feb 2026 (actual). Primary completion is estimated for Sep 2026, 6 months after the start.
Of 164 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 6 months is below that.
Counting every sponsor, half of 172 studies reached it within 25 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Epinephrine
Nishtar Medical University