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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Fluid Refractory Septic Shock
• Intervention / Treatment: Drug: Adrenaline; Drug: Dopamine

Detailed Description

This is a randomized control trial in which children / patients diagnosed with Fluid refractory Septic shock will be provided with one of the two drugs ina randomzied way and their efficacy will be assesed on the basis of correction of various parameters at various points of time.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hafiz Muhammad Abdullah Dr, MBBS; Phone Number: 03440846288; Email: mbilal1857@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Faisalābad, Punjab Province, Pakistan, 38000
      • Recruiting
      • The Children Hospital and The Institute of Child Health Faisalabad
      • Contact: Zahid Mahmood Dr, MBBS, FCPS; Phone Number: 03336507982; Email: zmahmoodch@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

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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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; These patients will receive 0.1-0.3ug/kg/min of adrenaline when diagnosed with fluid refractory Septic shock .	Drug: Adrenaline; 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
Active Comparator: Group B; The patients in this arm of study will be provided with dopamine 10-20ug/kg/min when diagnosed with fluid refractory septic shock.	Drug: Dopamine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA ( Sequential Organ Failure Assesment)	SOFA ( Sequential Organ Failure Assesment) score will be calculated afte adminitration of each drug at 20mins and 6 hours	6 Hours

Collaborators and Investigators

• Sponsor: Laiba Qamar

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Septic Shock; Dopamine; Adrenaine; Fluid refractory septic shock
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Epinephrine; Dopamine
• Other Study ID Numbers: #AVDSSC24#

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No