Fluid Refractory Septic ShockNCT07273526
Adrenaline V/s Dopamine in Fuid Refractory Septic Shock
A study testing Adrenaline and Dopamine in people with Fluid Refractory Septic Shock and Septic Shock, run by Laiba Qamar at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Fluid Refractory Septic Shock, Septic Shock
- What is being tested?
- Adrenaline and Dopamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of both Genders having age range between 1month and 12 years with diagnosis of fluid refractory septic shock as per operational definition.
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
The Children Hospital and The Institute of Child Health Faisalabad
Faisalābad, Punjab Province, 38000
Zahid Mahmood Dr, MBBS, FCPS, 03336507982, zmahmoodch@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fluid Refractory Septic Shock, Septic Shock
- Being tested
- Adrenaline, Dopamine
- Keywords
- Septic Shock, Adrenaine, Dopamine, Fluid refractory septic shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
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
DopamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | These patients will receive 0.1-0.3ug/kg/min of adrenaline when diagnosed with fluid refractory Septic shock . Receives: 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. Receives: Drug: Dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
The blood pressure of the patients will be meaures after administration of each drug at 20 mins and 6 hours.
Measured: 6 hours
Pulse
The pulse will be compared after adminitration of both drugs at 20 mins and 6 hours
Measured: 6 hours
Capillary Refill Time
Capillary Refill time will be assessed after administration of each drug at 20 mins and 6 hours
Measured: 6 Hours
Urine output
Urine output will be calculated from the time of administration of each drug at 20mins and 6 hours and comapred.
Measured: 6 hours
GCS
Glascow Comma Scale (GCS) will be asses at 20 mins and 6 hours after administration of each drug
Measured: 6 hours
Secondary outcomes (1)
SOFA ( Sequential Organ Failure Assesment)
SOFA ( Sequential Organ Failure Assesment) score will be calculated afte adminitration of each drug at 20mins and 6 hours
Measured: 6 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Refractory Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laiba Qamar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laiba Qamar, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273526
- Sponsor's protocol ID
- #AVDSSC24#
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Renaline and Dopamine in the Treatment of Fluid Refractory Septic Shock in Children
- ClinicalTrials.gov ID
- NCT07273526
- Acronym / sponsor ID
- #AVDSSC24#
- Conditions
- Fluid Refractory Septic Shock, Septic Shock
- Keywords
- Septic Shock, Adrenaine, Dopamine, Fluid refractory septic shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Laiba QamarUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: AdrenalineThese patients will receive 0.1-0.3ug/kg/min of adrenaline when diagnosed with fluid refractory Septic shock . |
| Group B | Active comparator | Drug: DopamineThe patients in this arm of study will be provided with dopamine 10-20ug/kg/min when diagnosed with fluid refractory septic shock. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients of both Genders having age range between 1month and 12 years with diagnosis of fluid refractory septic shock as per operational definition.
- -
Key exclusion criteria (6 listed)
- Patients with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdrenalineThe 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 | Drug | Group A |
| DopamineThe 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. | Drug | Group B |
Primary outcome
Blood Pressure
Time frame: 6 hours
The blood pressure of the patients will be meaures after administration of each drug at 20 mins and 6 hours.
Pulse
Time frame: 6 hours
The pulse will be compared after adminitration of both drugs at 20 mins and 6 hours
Capillary Refill Time
Time frame: 6 Hours
Capillary Refill time will be assessed after administration of each drug at 20 mins and 6 hours
Urine output
Time frame: 6 hours
Urine output will be calculated from the time of administration of each drug at 20mins and 6 hours and comapred.
GCS
Time frame: 6 hours
Glascow Comma Scale (GCS) will be asses at 20 mins and 6 hours after administration of each drug
1 secondary outcome
SOFA ( Sequential Organ Failure Assesment)
Time frame: 6 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Fluid Refractory Septic Shock
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Management of Shock in Children With SAM or Severe Underweight and Diarrhea
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Not yet recruitingPhase 2/3
Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Neonatal Sepsis, Shock, Septic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenaline and Dopamine in people with Fluid Refractory Septic Shock and Septic Shock, run by Laiba Qamar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafiz Muhammad Abdullah Dr, MBBS (03440846288, mbilal1857@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 6 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.