SepsisPhase 2AFLUDROS-1NCT07451886
Adjunctive Fludrocortisone in Septic Shock
A Phase 2 study testing Fludrocortisone 100 mcg daily in people with Sepsis and Septic Shock, run by Chinese University of Hong Kong at 5 sites in Hong Kong.
Trial summary
Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis - to Reduce Mortality in the Intensive Care Unit
- What is being tested?
- Fludrocortisone 100 mcg daily
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 5 sitesHong Kong
- Study dates
- 1 Apr 2026to 31 Jul 2028
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
- ≥0.25 μg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour
- onset of septic shock within 24 hours
- shock due to infection with no other proven or apparent cause
- hypoperfusion defined as arterial or venous lactate concentration >2.0 mmol/L
- mechanical ventilation
Who cannot join
- fludrocortisone cannot be administered within 24 hours of onset of septic shock
- death is deemed imminent or inevitable by treating clinicians
- limitation of therapy
- an underlying disease process with a life expectancy of less than 90 days
- pregnancy (confirmed or suspected)
- receiving immunomodulatory agents including hydrocortisone > 300mg/day
Show all 9Show fewer
- enteral medication cannot be administered
- prescribed fludrocortisone for other medical condition
- contraindication to hydrocortisone or fludrocortisone
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Hong Kong5 sites, 5 recruiting
- Not yet recruiting
North District Hospital
Hong Kong
- Not yet recruiting
Pamela Youde Nethersole Hospital
Hong Kong
- Recruiting
Prince of Wales Hospital
Hong Kong
Ling Lowell, MBBS, +852 35051311, lowell.ling@cuhk.edu.hk
- Not yet recruiting
Princess Margaret Hospital
Hong Kong
- Not yet recruiting
Queen Mary Hospital
Hong Kong
About this study
Official title: Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)
Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone.
To test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.
Read the detailed description
Design: Pilot, multicenter, randomized, double-blind, placebo-controlled trial on use of adjunctive fludrocortisone in critically ill patients with septic shock.
Objective: Determine feasibility of conducting a large, international, multicenter, double-blind, randomized, placebo controlled efficacy trial of adjunctive fludrocortisone to improve septic shock mortality.
Setting: 6 intensive care units (ICU) in Hong Kong, Australia and Singapore. Participants: 32 adult participants with suspected or confirmed septic shock within 24 hours of onset of shock and mechanical ventilation. Exclusion criteria are pregnancy, limitation of therapy, prescribed fludrocortisone for other medical condition, fludrocortisone cannot be administered within 24 hours of shock onset.
Interventions: Enteral 100 mcg fludrocortisone daily or placebo for up to 7 days or until death or discharge from ICU, whichever comes first.
Main outcome measures: Primary outcome is fulfillment of all pre-specified endpoints of feasibility criteria: protocol deviation <15%, lost of concealment <10%, drop out rate <10% and missing data <10%. Secondary outcomes include monthly recruitment rate, time to resolution of shock, 28-day mortality, days alive and free from organ support, severe electrolyte abnormality.
Data analysis: Each feasibility criterion will be assessed amongst all study participants. Intention to treat analysis will be used to calculate differences in secondary outcomes between treatment groups.
Expected results: Feasibility criteria will be met and demonstrate potential to scale-up to a large, international, multicenter, double-blind, randomized, placebo-controlled trial of adjunctive fludrocortisone to improve septic shock mortality.
- Conditions
- Sepsis, Septic Shock, Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
- Being tested
- Fludrocortisone 100 mcg daily, Placebo
- Keywords
- Fludrocortisone, Septic shock, Sepsis, hydrocortisone, intensive care unit, pilot
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludrocortisone 100 mcg dailyDrug
Patients will be given enteral fludrocortisone 100 mcg daily for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.
PlaceboDrug
Patients will be given an enteral placebo tablet for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Fludrocortisone | Experimental | Not described Receives: Drug: Fludrocortisone 100 mcg daily |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Protocol deviations < 15%
Defined as <15% of recruited subjects that had at least one protocol deviation during the duration of intervention
Measured: End of study approximately 20 months
Number of Lost of concealment < 10%
Defined as <10% of recruited subjects that lost blinding of allocations to either the patient, clinical or trial statistician
Measured: End of study approximately 20 months
Number of Drop out < 10%
Defined as <10% of recruited subjects who drop out of the study after recruitment
Measured: End of study approximately 20 months
Number of Missing data < 10%
Defined as <10% of data with missing values for each data category including lost to follow up
Measured: End of study approximately 20 months
Secondary outcomes (9)
Number of Monthly Recruitment
Defined as the number of patients recruited per month across all study sites. In addition, screening and exclusion of subjects will be reported to inform the recruitment process and target study population of a future definitive trial.
Measured: End of study approximately 20 months
Time to resolution of shock
Defined as time from randomization to attainment of a clinician-prescribed MAP target of >24 hours without use of vasopressor or inotropes
Measured: Until patient discharge from ICU
28-day mortality
Defined as mortality in the first 28 days after randomization
Measured: First 28 days after enrollment
Days alive and vasopressor-free until day 28
Defined as days alive without need for vasopressors or inotropes in the first 28 days after randomization
Measured: First 28 days after enrollment
Days alive and ventilator-free until day 28
Defined as days alive without mechanical ventilation in the first 28 days after randomization
Measured: First 28 days after enrollment
Days alive and dialysis-free until day 28
Defined as days alive without any forms of renal replacement therapy in the first 28 days after randomization
Measured: First 28 days after enrollment
Days alive and free from organ support
Defined as days alive without need for mechanical ventilation, vasopressors or dialysis in the first 28 days after randomization
Measured: First 28 days after enrollment
Number of new onset infections
Defined as new nosocomial infection 2 days after randomization until the first 28 days after randomization
Measured: First 28 days after enrollment
Severe electrolyte abnormality
Defined as plasma sodium ≥ 155 mmol/L or potassium ≤ 2.5 mmol/L during the first 7 days after randomization
Measured: First 7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, multicenter, randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lowell Ling, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451886
- Sponsor's protocol ID
- 2024.398
- Acronym
- AFLUDROS-1
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)
- ClinicalTrials.gov ID
- NCT07451886
- Acronym / sponsor ID
- AFLUDROS-1 / 2024.398
- Conditions
- Sepsis, Septic Shock, Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
- Keywords
- Fludrocortisone, Septic shock, Sepsis, hydrocortisone, intensive care unit, pilot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 5 Mar 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.
Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone.
To test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.
Detailed description
Design: Pilot, multicenter, randomized, double-blind, placebo-controlled trial on use of adjunctive fludrocortisone in critically ill patients with septic shock.
Objective: Determine feasibility of conducting a large, international, multicenter, double-blind, randomized, placebo controlled efficacy trial of adjunctive fludrocortisone to improve septic shock mortality.
Setting: 6 intensive care units (ICU) in Hong Kong, Australia and Singapore. Participants: 32 adult participants with suspected or confirmed septic shock within 24 hours of onset of shock and mechanical ventilation. Exclusion criteria are pregnancy, limitation of therapy, prescribed fludrocortisone for other medical condition, fludrocortisone cannot be administered within 24 hours of shock onset.
Interventions: Enteral 100 mcg fludrocortisone daily or placebo for up to 7 days or until death or discharge from ICU, whichever comes first.
Main outcome measures: Primary outcome is fulfillment of all pre-specified endpoints of feasibility criteria: protocol deviation <15%, lost of concealment <10%, drop out rate <10% and missing data <10%. Secondary outcomes include monthly recruitment rate, time to resolution of shock, 28-day mortality, days alive and free from organ support, severe electrolyte abnormality.
Data analysis: Each feasibility criterion will be assessed amongst all study participants. Intention to treat analysis will be used to calculate differences in secondary outcomes between treatment groups.
Expected results: Feasibility criteria will be met and demonstrate potential to scale-up to a large, international, multicenter, double-blind, randomized, placebo-controlled trial of adjunctive fludrocortisone to improve septic shock mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot, multicenter, randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Fludrocortisone | Experimental | Drug: Fludrocortisone 100 mcg daily |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
- ≥0.25 μg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour
- onset of septic shock within 24 hours
- shock due to infection with no other proven or apparent cause
- hypoperfusion defined as arterial or venous lactate concentration >2.0 mmol/L
Key exclusion criteria (9 listed)
- fludrocortisone cannot be administered within 24 hours of onset of septic shock
- death is deemed imminent or inevitable by treating clinicians
- limitation of therapy
- an underlying disease process with a life expectancy of less than 90 days
- pregnancy (confirmed or suspected)
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 |
|---|---|---|
| Fludrocortisone 100 mcg dailyPatients will be given enteral fludrocortisone 100 mcg daily for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first. | Drug | Fludrocortisone |
| PlaceboPatients will be given an enteral placebo tablet for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first. | Drug | Placebo |
Primary outcome
Number of Protocol deviations < 15%
Time frame: End of study approximately 20 months
Defined as <15% of recruited subjects that had at least one protocol deviation during the duration of intervention
Number of Lost of concealment < 10%
Time frame: End of study approximately 20 months
Defined as <10% of recruited subjects that lost blinding of allocations to either the patient, clinical or trial statistician
Number of Drop out < 10%
Time frame: End of study approximately 20 months
Defined as <10% of recruited subjects who drop out of the study after recruitment
Number of Missing data < 10%
Time frame: End of study approximately 20 months
Defined as <10% of data with missing values for each data category including lost to follow up
9 secondary outcomes
Number of Monthly Recruitment
Time frame: End of study approximately 20 months
Time to resolution of shock
Time frame: Until patient discharge from ICU
28-day mortality
Time frame: First 28 days after enrollment
Days alive and vasopressor-free until day 28
Time frame: First 28 days after enrollment
Days alive and ventilator-free until day 28
Time frame: First 28 days after enrollment
Days alive and dialysis-free until day 28
Time frame: First 28 days after enrollment
Days alive and free from organ support
Time frame: First 28 days after enrollment
Number of new onset infections
Time frame: First 28 days after enrollment
Severe electrolyte abnormality
Time frame: First 7 days after enrollment
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 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludrocortisone 100 mcg daily in people with Sepsis and Septic Shock, run by Chinese University of Hong Kong at 5 sites in Hong Kong.
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 6 inclusion and 9 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 2 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 5 sites in Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lowell Ling, MBBS ((852) 35052735, lowell.ling@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Protocol deviations < 15% (time frame: End of study approximately 20 months). The study lists 4 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 2 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.