Septic ShockNCT07313670
Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock
A study testing Intravenous Hydrocortisone in people with Septic Shock, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Although, hydrocortisone has shown promise in managing refractory shock, its role in early septic shock management remains unclear. This study aims to provide robust evidence on the clinical and hemodynamic outcomes of early hydrocortisone use in pediatric septic shock, contributing to standardized treatment protocols… Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Intravenous Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of any gender
- Aged 2 month to 12 years
- Diagnosed with septic shock
- Admitted to the pediatric intensive care unit
Who cannot join
- Known adrenal insufficiency or congenital adrenal hyperplasia
- History of corticosteroid use within the past 7 days
- Terminal illness or "do-not-resuscitate (DNR)" status
- Severe immunocompromise (e.g., advanced malignancy, HIV stage IV)
- Known allergy to hydrocortisone
Trial locations and contacts
1 site in 1 country.
About this study
Although, hydrocortisone has shown promise in managing refractory shock, its role in early septic shock management remains unclear. This study aims to provide robust evidence on the clinical and hemodynamic outcomes of early hydrocortisone use in pediatric septic shock, contributing to standardized treatment protocols and improved survival rates.
Read the detailed description
Despite global advancements in pediatric critical care, mortality and morbidity in septic shock remain unacceptably high. Although data suggest a reduction in mortality with steroid therapy in refractory shock, specific data for hydrocortisone in pediatrics are limited. The findings of this study would not only be a valuable addition to the existing stats but might also help develop a protocol for the use of hydrocortisone therapy in children with septic shock, seeking an earlier recovery from organ failure, earlier reversal of shock, and lower mortality in children with sepsis and septic shock.
- Conditions
- Septic Shock
- Being tested
- Intravenous Hydrocortisone, Standard care
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous HydrocortisoneDrug
Children will receive early intravenous hydrocortisone at 2 mg/kg/day divided every 6 hours, continued for 7 days or until resolution of shock.
Standard careDrug
The children will be managed by following standard institutional treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone Group | Experimental | Children will receive early intravenous hydrocortisone at 2 mg/kg/day divided every 6 hours, continued for 7 days or until resolution of shock. Receives: Drug: Intravenous Hydrocortisone; Drug: Standard care |
| Standard Care Group | Experimental | The children will be managed by following standard institutional treatment protocol. Receives: Drug: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The mortality will be labeled 'yes' if a patient dies within 28 days of admission.
Measured: 28 days
Secondary outcomes (2)
Duration of vasopressor
Vasopressor therapy time will be computed from the start of treatment until hemodynamic stability is attained.
Measured: 28 days
Length of pediatric intensive care unit stay
The time will be calculated from admission in the pediatric intensive care unit until discharge or mortality.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jul 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Jawaria Ibrahim, Principal investigator, Department of Pediatrics, Abbasi Shaheed Hospital Karachi, PakistanIbrahim Shakoor, FCPS, Study director, Department of Pediatrics, Abbasi Shaheed Hospital Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313670
- Sponsor's protocol ID
- DR-JAWARIA-KARACHI
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock
- ClinicalTrials.gov ID
- NCT07313670
- Acronym / sponsor ID
- DR-JAWARIA-KARACHI
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 2 Jan 2026 (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.
Although, hydrocortisone has shown promise in managing refractory shock, its role in early septic shock management remains unclear. This study aims to provide robust evidence on the clinical and hemodynamic outcomes of early hydrocortisone use in pediatric septic shock, contributing to standardized treatment protocols and improved survival rates.
Detailed description
Despite global advancements in pediatric critical care, mortality and morbidity in septic shock remain unacceptably high. Although data suggest a reduction in mortality with steroid therapy in refractory shock, specific data for hydrocortisone in pediatrics are limited. The findings of this study would not only be a valuable addition to the existing stats but might also help develop a protocol for the use of hydrocortisone therapy in children with septic shock, seeking an earlier recovery from organ failure, earlier reversal of shock, and lower mortality in children with sepsis and septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone Group | Experimental | Drug: Intravenous Hydrocortisone, Drug: Standard careChildren will receive early intravenous hydrocortisone at 2 mg/kg/day divided every 6 hours, continued for 7 days or until resolution of shock. |
| Standard Care Group | Experimental | Drug: Standard careThe children will be managed by following standard institutional treatment protocol. |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of any gender
- Aged 2 month to 12 years
- Diagnosed with septic shock
- Admitted to the pediatric intensive care unit
Key exclusion criteria (5 listed)
- Known adrenal insufficiency or congenital adrenal hyperplasia
- History of corticosteroid use within the past 7 days
- Terminal illness or "do-not-resuscitate (DNR)" status
- Severe immunocompromise (e.g., advanced malignancy, HIV stage IV)
- Known allergy to hydrocortisone
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 |
|---|---|---|
| Intravenous HydrocortisoneChildren will receive early intravenous hydrocortisone at 2 mg/kg/day divided every 6 hours, continued for 7 days or until resolution of shock. | Drug | Hydrocortisone Group |
| Standard careThe children will be managed by following standard institutional treatment protocol. | Drug | Hydrocortisone Group, Standard Care Group |
Primary outcome
Mortality
Time frame: 28 days
The mortality will be labeled 'yes' if a patient dies within 28 days of admission.
2 secondary outcomes
Duration of vasopressor
Time frame: 28 days
Length of pediatric intensive care unit stay
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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. This study is not recruiting at the moment.
Jawaria Ibrahim principal investigator
Department of Pediatrics, Abbasi Shaheed Hospital Karachi, Pakistan
Ibrahim Shakoor, FCPS study director
Department of Pediatrics, Abbasi Shaheed Hospital Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Hydrocortisone in people with Septic Shock, run by Muhammad Aamir Latif 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). 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 29 Jun 2026.