NCT07273526

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

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

Septic ShockAdrenaineDopamineFluid refractory septic shock

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

EXPERIMENTAL

These patients will receive 0.1-0.3ug/kg/min of adrenaline when diagnosed with fluid refractory Septic shock .

Drug: Adrenaline

Group B

ACTIVE COMPARATOR

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

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

Group A

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.

Group B

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

The Children Hospital and The Institute of Child Health Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

EpinephrineDopamine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Hafiz Muhammad Abdullah Dr, MBBS

CONTACT

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

Locations