Septic ShockPhase 3FLUDRONCT02069288
Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock
A Phase 3 study testing Fludrocortisone in people with Septic Shock, run by Rennes University Hospital at 1 site in France.
Trial summary
Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Fludrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Feb 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over than 18 years old
- Septic shock
- Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min
- Written informed consent
Who cannot join
- Corticotherapy
- Known allergy to Fludrocortisone
- Esophageal or gastric disease
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Chirurgicale - Hôpital de Pontchaillou
Rennes, 35033
About this study
Official title: Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock
Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.
- Conditions
- Septic Shock
- Being tested
- Fludrocortisone, Placebo
- Keywords
- fludrocortisone, pharmacology, 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.
FludrocortisoneDrug
Also called 9- alpha- fluorohydrocortisone
50 µg of fludrocortisone per os
PlaceboDrug
1 tablet of placebo per os
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fludrocortisone Receives: Drug: Fludrocortisone |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Norepinephrine-mean arterial pressure dose-response relationship
Measured: 1.5 h after administration
Secondary outcomes (8)
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Measured: During 3 h after administration
Central aortic pressures, Augmentation Index (Aix).
Measured: During 3 h after administration
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Measured: During 3 h after administration
Humeral diameter and distensibility
Measured: During 3 h after administration
Gastric mucosal perfusion
Measured: During 3 h after administration
Plasma electrolytes, blood glucose, serum creatinine
Measured: Each hour during 3 h after administration
Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations
Measured: Each hour during 3 h after administration
Urinary electrolytes excretion
Measured: Each hour during 3 h after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Problems of drugs supply by the manufacturer
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.
- More trials run by Rennes University HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno LAVIOLLE, MD, Principal investigator, Rennes University HospitalEric BELLISSANT, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069288
- Sponsor's protocol ID
- EudraCT 2007-007971-18
- Other IDs
- CIC0203/082
- Acronym
- FLUDRO
- Status last verified
- Feb 2014
- First submitted
- 23 Dec 2013
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock
- ClinicalTrials.gov ID
- NCT02069288
- Acronym / sponsor ID
- FLUDRO / EudraCT 2007-007971-18
- Conditions
- Septic Shock
- Keywords
- fludrocortisone, pharmacology, septic shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems of drugs supply by the manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- 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.
Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FludrocortisoneFludrocortisone |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over than 18 years old
- Septic shock
- Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min
- Written informed consent
Key exclusion criteria (4 listed)
- Corticotherapy
- Known allergy to Fludrocortisone
- Esophageal or gastric disease
- Pregnant woman
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 |
|---|---|---|
| FludrocortisoneAlso: 9- alpha- fluorohydrocortisone50 µg of fludrocortisone per os | Drug | 1 |
| Placebo1 tablet of placebo per os | Drug | 2 |
Primary outcome
Norepinephrine-mean arterial pressure dose-response relationship
Time frame: 1.5 h after administration
8 secondary outcomes
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Time frame: During 3 h after administration
Central aortic pressures, Augmentation Index (Aix).
Time frame: During 3 h after administration
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Time frame: During 3 h after administration
Humeral diameter and distensibility
Time frame: During 3 h after administration
Gastric mucosal perfusion
Time frame: During 3 h after administration
Plasma electrolytes, blood glucose, serum creatinine
Time frame: Each hour during 3 h after administration
Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations
Time frame: Each hour during 3 h after administration
Urinary electrolytes excretion
Time frame: Each hour during 3 h after administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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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. This study is not recruiting at the moment.
Bruno LAVIOLLE, MD principal investigator
Rennes University Hospital
Eric BELLISSANT, MD, PhD study chair
Rennes University Hospital
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 Fludrocortisone in people with Septic Shock, run by Rennes University Hospital 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 Feb 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Norepinephrine-mean arterial pressure dose-response relationship (time frame: 1.5 h after administration). 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 24 Feb 2014.