Adrenaline versus dopamine for children with fluid-refractory septic shock
Comparison of the Efficacy of Renaline and Dopamine in the Treatment of Fluid Refractory Septic Shock in Children
NA · University of Health Sciences Lahore · NCT07273526
This trial will see if adrenaline or dopamine works better to stabilize children (1 month–12 years) whose septic shock does not improve after fluid treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Month to 12 Months |
| Sex | All |
| Sponsor | University of Health Sciences Lahore (other) |
| Locations | 1 site (Faisalābad, Punjab Province) |
| Trial ID | NCT07273526 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial enrolling children with fluid-refractory septic shock who are randomized to receive either adrenaline or dopamine. Treatments are compared by monitoring heart rate, Glasgow Coma Scale, capillary refill time, palpable peripheral pulses, urine output, and systolic blood pressure at predefined time points. The trial is conducted at a single pediatric tertiary center in Faisalabad and follows patients through early hemodynamic response. Children with recent cardiopulmonary bypass, major chronic systemic, neuromuscular, or metabolic disorders, or incomplete prior treatment records are excluded.
Who should consider this trial
Good fit: Children aged 1 month to 12 years with a diagnosis of fluid-refractory septic shock who meet the trial's operational definition and do not meet exclusion criteria are appropriate candidates.
Not a fit: Children with recent cardiopulmonary bypass, chronic systemic illnesses (like chronic kidney disease, cerebral palsy, or congenital heart disease), neuromuscular or metabolic disorders, or those treated elsewhere without records are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify which vasopressor restores circulation faster and reduces complications in children with fluid-refractory septic shock.
How similar studies have performed: Other pediatric and adult trials have compared epinephrine/adrenaline and dopamine with mixed results, so further randomized pediatric data are needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients of both Genders having age range between 1month and 12 years with diagnosis of fluid refractory septic shock as per operational definition. \- Exclusion Criteria: * Patients with 1. cardiopumonary Bypass during last 5 days 2. Chronic Systemic disease like Chronic kidney Disease , cerebral palsy, congenital heart disease 3. neuromuscular discorder 4. Metabolic disorders 5. Those who already had treatment at periphery for hypovolemia without any record of medication or sequential organ failure at presentation
Where this trial is running
Faisalābad, Punjab Province
- The Children Hospital and The Institute of Child Health Faisalabad — Faisalābad, Punjab Province, Pakistan (RECRUITING)
Study contacts
- Study coordinator: Hafiz Muhammad Abdullah Dr, MBBS
- Email: mbilal1857@gmail.com
- Phone: 03440846288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fluid Refractory Septic Shock, Septic Shock, Adrenaine, Dopamine, Fluid refractory septic shock