Inflammation in Cardiac SurgeryPhase 3VASOCORTNCT07037043
Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery
A Phase 3 study testing hydrocortisone plus fludrocortisone in people with Inflammation in Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation in Cardiac Surgery
- What is being tested?
- hydrocortisone plus fludrocortisone
- 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
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to Jun 2028
- Phase
- Phase 3
- 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
- Age > 18 years.
- Patient at intermediate/high risk (EuroSCORE II > 4%).
- Patient admitted for scheduled cardiac surgery:
- Coronary artery bypass grafting (CABG).
- Aortic valve replacement.
- Mitral valve repair or replacement.
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- Surgery of the aortic root (aortic tube, Bentall procedure, Tirone David procedure, or other).
- Combined surgery.
- Patient undergoing cardiopulmonary bypass (CPB).
- Informed consent signed by the patient.
Who cannot join
- Endocarditis
- Off-pump heart surgery
- Heart transplantation or long-term ventricular assist device (VAD)
- Emergency surgery: aortic dissection, emergency coronary artery bypass grafting (CABG)
- Failure to wean from CPB requiring short-term mechanical support (intra-aortic balloon pump, ECMO)
- Hypothermic surgery
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- History of cardiac surgery
- Patient on long-term corticosteroid therapy
- Autoimmune disease or chronic inflammatory condition
- End-stage renal disease on long-term dialysis
- Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the summary of product characteristics (SmPC)
- Pregnant or breastfeeding woman
- Patient under legal protection (guardianship, curators, or judicial safeguard).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens, 80480
Christophe Beyls, MD, 33+3 22 08 78 66, Beyls.christophe@chu-amiens.fr
Osama Abou Arab, Pr
About this study
Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced.
In some cases, the immune response might be dysregulated with a more pronounced pro inflammatory state that compromises organ perfusion and with the occurrence of organ failure. From a mechanistic approach, the relationship between organ failure is complex and multifactorial with a high level of proinflammatory cytokines, a decrease in microcirculation, an endothelial dysfunction and an activation of coagulation and over. The clinical expression is an increase in vasopressor exposure and dose, an increase in mortality and in adverse outcomes with a predominance of acute kidney injury.
Read more
Various therapies have been assessed to manage cardiac surgery related sepsis including glucocorticoid therapy. Briefly, two major randomized trials assessed glucocorticoid therapy solely in scheduled cardiac surgery with cardiopulmonary bypass. No clinical benefit was demonstrated in term of reduction in postoperative mortality or adverse outcomes. Since, data support that the selection of patients at risk is crucial to demonstrate such a strategy. Indeed, data support that surprisingly some patients will have a very light immune response reflected by a low pro inflammatory cytokine.
The hypothesis is that the combination glucocorticoid and fludrocortisone could decrease adverse outcomes in selected patients.
- Conditions
- Inflammation in Cardiac Surgery
- Being tested
- hydrocortisone plus fludrocortisone, placebo of hydrocortisone plus fludrocortisone
- Keywords
- Control of inflammation in cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisone plus fludrocortisoneDrug
- Hydrocortisone 200 mg/day for 5 days or until ICU discharge, starting at the initiation of cardiopulmonary bypass (CPB), administered intravenously via syringe pump in a double-blind manner
- Fludrocortisone 50 µg/day in the morning for 5 days or until ICU discharge, administered orally or via nasogastric tube (if the patient is sedated), diluted in a glass of water, in a double-blind manner
placebo of hydrocortisone plus fludrocortisoneDrug
- Placebo for hydrocortisone (0.9% NaCl) administered following the same protocol as fludrocortisone in the intervention group
- Placebo for fludrocortisone (capsule containing microcrystalline cellulose diluted in a glass of water) administered following the same protocol as fludrocortisone in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| hydrocortisone plus fludrocortisone | Experimental | * Hydrocortisone 200 mg/day for 5 days or until ICU discharge, starting at the initiation of cardiopulmonary bypass (CPB), administered intravenously via syringe pump in a double-blind manner
* Fludrocortisone 50 µg/day in the morning for 5 days or until ICU discharge, administered orally or via nasogastric tube (if the patient is sedated), diluted in a glass of water, in a double-blind manner Receives: Drug: hydrocortisone plus fludrocortisone |
| placebo of hydrocortisone plus fludrocortisone | Placebo comparator | * Placebo for hydrocortisone (0.9% NaCl) administered following the same protocol as fludrocortisone in the intervention group
* Placebo for fludrocortisone (capsule containing microcrystalline cellulose diluted in a glass of water) administered following the same protocol as fludrocortisone in the intervention group Receives: Drug: placebo of hydrocortisone plus fludrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of acute kidney injury occurence between both groups
Measured: up to 7 days
Variation of postoperative pulmonary complication occurrence between both groups
Measured: up to 7 days
Variation of number of norepinephrine requirement between both groups
Measured: up to 7 days
Secondary outcomes (6)
variation of postoperative atrial fibrillation occurence between both groups
Postoperative atrial fibrillation: defined as a new-onset arrhythmia within 7 days after surgery, documented by an electrocardiogram showing absence of P waves and narrow, irregular QRS complexes
Measured: up to 7 days
variation of myocardial infarction occurence between both groups
Myocardial infarction: defined according to the Fourth Universal Definition
Measured: up to 7 days
variation of stroke occurence between both groups
Stroke: defined as the sudden onset of a neurological deficit confirmed by brain imaging
Measured: up to 7 days
Variation of total amount of norepinephrine between both groups
The total amount of norepinephrine will be expressed in milligrams and will correspond to the cumulative dose administered from ICU admission until the 7th postoperative day.
Measured: up to 7 days
variation of occurrence of glucocorticoid side effect between both groups
glucocorticoid side effects are hyperglycemia, hypernatremia and infections
Measured: up to 7 days
Variation of 28-day mortality between both groups
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start30 Apr 2025
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation in Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037043
- Sponsor's protocol ID
- PI2024_843_0047
- Acronym
- VASOCORT
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07037043
- Acronym / sponsor ID
- VASOCORT / PI2024_843_0047
- Conditions
- Inflammation in Cardiac Surgery
- Keywords
- Control of inflammation in cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Lille
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Jun 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.
Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced.
In some cases, the immune response might be dysregulated with a more pronounced pro inflammatory state that compromises organ perfusion and with the occurrence of organ failure. From a mechanistic approach, the relationship between organ failure is complex and multifactorial with a high level of proinflammatory cytokines, a decrease in microcirculation, an endothelial dysfunction and an activation of coagulation and over. The clinical expression is an increase in vasopressor exposure and dose, an increase in mortality and in adverse outcomes with a predominance of acute kidney injury.
Various therapies have been assessed to manage cardiac surgery related sepsis including glucocorticoid therapy. Briefly, two major randomized trials assessed glucocorticoid therapy solely in scheduled cardiac surgery with cardiopulmonary bypass. No clinical benefit was demonstrated in term of reduction in postoperative mortality or adverse outcomes. Since, data support that the selection of patients at risk is crucial to demonstrate such a strategy. Indeed, data support that surprisingly some patients will have a very light immune response reflected by a low pro inflammatory cytokine.
The hypothesis is that the combination glucocorticoid and fludrocortisone could decrease adverse outcomes in selected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrocortisone plus fludrocortisone | Experimental | Drug: hydrocortisone plus fludrocortisone* Hydrocortisone 200 mg/day for 5 days or until ICU discharge, starting at the initiation of cardiopulmonary bypass (CPB), administered intravenously via syringe pump in a double-blind manner * Fludrocortisone 50 µg/day in the morning for 5 days or until ICU discharge, administered orally or via nasogastric tube (if the patient is sedated), diluted in a glass of water, in a double-blind manner |
| placebo of hydrocortisone plus fludrocortisone | Placebo comparator | Drug: placebo of hydrocortisone plus fludrocortisone* Placebo for hydrocortisone (0.9% NaCl) administered following the same protocol as fludrocortisone in the intervention group * Placebo for fludrocortisone (capsule containing microcrystalline cellulose diluted in a glass of water) administered following the same protocol as fludrocortisone in the intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years.
- Patient at intermediate/high risk (EuroSCORE II > 4%).
- Patient admitted for scheduled cardiac surgery:
- Patient undergoing cardiopulmonary bypass (CPB).
- Informed consent signed by the patient.
Key exclusion criteria (13 listed)
- Endocarditis
- Off-pump heart surgery
- Heart transplantation or long-term ventricular assist device (VAD)
- Emergency surgery: aortic dissection, emergency coronary artery bypass grafting (CABG)
- Failure to wean from CPB requiring short-term mechanical support (intra-aortic balloon pump, ECMO)
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 |
|---|---|---|
| hydrocortisone plus fludrocortisone* Hydrocortisone 200 mg/day for 5 days or until ICU discharge, starting at the initiation of cardiopulmonary bypass (CPB), administered intravenously via syringe pump in a double-blind manner * Fludrocortisone 50 µg/day in the morning for 5 days or until ICU discharge, administered orally or via nasogastric tube (if the patient is sedated), diluted in a glass of water, in a double-blind manner | Drug | hydrocortisone plus fludrocortisone |
| placebo of hydrocortisone plus fludrocortisone* Placebo for hydrocortisone (0.9% NaCl) administered following the same protocol as fludrocortisone in the intervention group * Placebo for fludrocortisone (capsule containing microcrystalline cellulose diluted in a glass of water) administered following the same protocol as fludrocortisone in the intervention group | Drug | placebo of hydrocortisone plus fludrocortisone |
Primary outcome
Variation of acute kidney injury occurence between both groups
Time frame: up to 7 days
Variation of postoperative pulmonary complication occurrence between both groups
Time frame: up to 7 days
Variation of number of norepinephrine requirement between both groups
Time frame: up to 7 days
6 secondary outcomes
variation of postoperative atrial fibrillation occurence between both groups
Time frame: up to 7 days
variation of myocardial infarction occurence between both groups
Time frame: up to 7 days
variation of stroke occurence between both groups
Time frame: up to 7 days
Variation of total amount of norepinephrine between both groups
Time frame: up to 7 days
variation of occurrence of glucocorticoid side effect between both groups
Time frame: up to 7 days
Variation of 28-day mortality between both groups
Time frame: at 28 days
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hydrocortisone plus fludrocortisone in people with Inflammation in Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 10 inclusion and 13 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 3 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Christophe Beyls, MD ((33)3 22 08 78 66, Beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of acute kidney injury occurence between both groups (time frame: up to 7 days). The study lists 3 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 3 Jun 2026.