Adrenaline V/s Dopamine in Fuid Refractory Septic Shock
Comparison of the Efficacy of Renaline and Dopamine in the Treatment of Fluid Refractory Septic Shock in Children
1 other identifier
interventional
90
1 country
1
Brief Summary
This study compares the efficacy of two drugs i.e Adrenaline and dopamine in fluid refractory type of septic shock which is a dreadful medical condition especially in children. The efficacy will be checked based on heart rate , GCS, capillary refill time , palpable pripheral pulse , urine output and systolic blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
November 26, 2025
CompletedFirst Posted
Study publicly available on registry
December 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 9, 2025
November 1, 2025
7 months
November 26, 2025
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Blood Pressure
The blood pressure of the patients will be meaures after administration of each drug at 20 mins and 6 hours.
6 hours
Pulse
The pulse will be compared after adminitration of both drugs at 20 mins and 6 hours
6 hours
Capillary Refill Time
Capillary Refill time will be assessed after administration of each drug at 20 mins and 6 hours
6 Hours
Urine output
Urine output will be calculated from the time of administration of each drug at 20mins and 6 hours and comapred.
6 hours
GCS
Glascow Comma Scale (GCS) will be asses at 20 mins and 6 hours after administration of each drug
6 hours
Secondary Outcomes (1)
SOFA ( Sequential Organ Failure Assesment)
6 Hours
Study Arms (2)
Group A
EXPERIMENTALThese patients will receive 0.1-0.3ug/kg/min of adrenaline when diagnosed with fluid refractory Septic shock .
Group B
ACTIVE COMPARATORThe patients in this arm of study will be provided with dopamine 10-20ug/kg/min when diagnosed with fluid refractory septic shock.
Interventions
The adrenaline will be given as a vasoconstrictor in the dose of 0.1-0.3ug/kg/min to the patients in group A when diagnosed with fluid refractory septic shock
The drug dopamine will be adminitered in dose of 10-20ug/kg/min to the patients of group B when diagnosed with fluid refractory septic shock.
Eligibility Criteria
You may qualify if:
- Patients of both Genders having age range between 1month and 12 years with diagnosis of fluid refractory septic shock as per operational definition.
You may not qualify if:
- Patients with
- cardiopumonary Bypass during last 5 days
- Chronic Systemic disease like Chronic kidney Disease , cerebral palsy, congenital heart disease
- neuromuscular discorder
- Metabolic disorders
- Those who already had treatment at periphery for hypovolemia without any record of medication or sequential organ failure at presentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laiba Qamarlead
Study Sites (1)
The Children Hospital and The Institute of Child Health Faisalabad
Faisalābad, Punjab Province, 38000, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
November 26, 2025
First Posted
December 9, 2025
Study Start
June 1, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
December 9, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share