Septic ShockPhase 2/3FLUDROSEPSISNCT05001854
Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline Septic Shock Patients
A Phase 2/3 study testing Fludrocortisone in people with Septic Shock, run by Rennes University Hospital at 1 site in France.
Trial summary
The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to Dec 2024
- Phase
- Phase 2/3
- 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
- Age > 18 years
- Patient with septic shock for less than 48 hours, defined by the combination of:
- Sepsis defined as organ dysfunction caused by an inappropriate host response to infection (increase in SOFA score of at least 2 points secondary to infection),
- Persistent hypotension requiring vasopressor drugs to maintain mean arterial pressure ≥ 65 mmHg,
- Hemodynamic stability for >30 min with mean arterial pressure ≥ 65 mmHg and noradrenaline dose ≤ 0.5 μg/kg/min,
- Consent signed by the patient, family member, or legal representative or inclusion under emergency procedure,
Show all 18Show fewer
- Negative to a diagnostic test for SARS-CoV2 less than 72 hours old; the test used must be on the the list published on the Ministry of Solidarity and Health website
- Non-inclusion Criteria:
- Current treatment with steroids or other treatment that may affect the hypothalamic-pituitary-adrenal axis,
- Anesthetic induction with etomidate within 6 hours prior to randomization given its selective inhibitory effect on 11 β-hydroxylase,
- Known hypersensitivity to fludrocortisone (or any of its excipients), or to tetracosactide (Synacthen®),
- Disturbed gastric emptying (gastric residue > 500 ml) in the absence of an alternative route of administration available (naso-jejunal tube or jejunostomy),
- Pregnant or nursing woman,
- Patient participating in another trial, possibly interfering with the study procedures,
- Person not affiliated to a social security system,
- Known situation of deprivation of freedom (safeguard of justice), guardianship or curatorship,
- Patient with a life expectancy of less than 24 hours.
- Patient with known or suspected SARS-CoV2 pneumonia
Who cannot join
- Patients under court protection will be excluded as soon as the investigator is aware of their status.
- Hemodynamic worsening with noradrenaline dose >1.5 μg/kg/min before evaluation of the primary end point.
- Catecholamine withdrawal before evaluation of the primary end point.
Trial locations and contacts
1 site in 1 country.
France1 site
Rennes University Hospital - Intensive Care unit
Rennes, Brittany Region, 35033
About this study
Official title: Evaluation of the Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline in Septic Shock Patients
The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative adrenal insufficiency. In a previous study in healthy volunteers, we showed for the first time that fludrocortisone at a dose of 400 μg per day significantly improved the pressor response to phenylephrine. These results confirm the observations reported in rats with endotoxin shock, where fludrocortisone was shown to significantly increase blood pressure and contractile response to phenylephrine. These encouraging results argue for a potential vascular beneficial effect of fludrocortisone and need to be confirmed in a population of septic shock patients. In this context, we aimed to evaluate the effect of oral administration of 100 μg every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in septic shock patients.
Read the detailed description
Patients admitted to medical and surgical intensive care units with septic shock who meet the selection criteria may be offered participation in the study. The consent is signed either by the patient or his or her relative/legal representative if he or she is not capable or the patient is included according to the emergency procedure in the absence of a relative. The patient is managed according to the usual procedures for patients in septic shock. After collection of the initial workup and basal measurements, the physician randomizes (=includes) the patient into one of 2 arms : the patient receives either fludrocortisone (400 μg per day), administered in 1 dose of 100 μg every 6 hours, i.e., 2 tablets of 50 μg per dose, or the placebo
- Conditions
- Septic Shock
- Being tested
- Fludrocortisone, Placebo
- 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 Flucortac
100 μg every 6 hours of fludrocortisone per os
PlaceboDrug
100 μg every 6 hours of placebo per os
| Study group | Role | What they receive |
|---|---|---|
| Fludrocortisone | Experimental | 100 μg every 6 hours of fludrocortisone per os
A pharmacokinetic study is performed in this arm Receives: Drug: Fludrocortisone |
| Control | Placebo comparator | 100 μg every 6 hours of placebo per os Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure (mmHg)
Mean arterial blood pressure (mmHg) after a dose escalation of norepinephrine in increments of 0.2 μg/kg/min to a maximum dose of 1.5 μg/kg/min.
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Secondary outcomes (49)
Heart rate
Heart rate
Measured: Baseline, before the first administration of the drug (fludrocortisone/placebo)
Heart rate
Heart rate
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Heart rate
Heart rate
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
Heart rate
Heart rate
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
arterial pressure
Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
arterial pressure
Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
arterial pressure
Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
arterial pressure
Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
Cardiac output
Cardiac output
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Cardiac output
Cardiac output
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Cardiac output
Cardiac output
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
Cardiac output
Cardiac output
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
Cardiac index
Cardiac index
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Cardiac index
Cardiac index
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Cardiac index
Cardiac index
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
Cardiac index
Cardiac index
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
Indexed Systemic Vascular Resistances (ISVR)
Indexed Systemic Vascular Resistances (ISVR)
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Indexed Systemic Vascular Resistances (ISVR)
Indexed Systemic Vascular Resistances (ISVR)
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Indexed Systemic Vascular Resistances (ISVR)
Indexed Systemic Vascular Resistances (ISVR)
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
Indexed Systemic Vascular Resistances (ISVR)
Indexed Systemic Vascular Resistances (ISVR)
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
Indexed Global Telediastolic Volume (IGVT)
Indexed Global Telediastolic Volume (IGVT)
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Indexed Global Telediastolic Volume (IGVT)
Indexed Global Telediastolic Volume (IGVT)
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Indexed Global Telediastolic Volume (IGVT)
Indexed Global Telediastolic Volume (IGVT)
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
Indexed Global Telediastolic Volume (IGVT)
Indexed Global Telediastolic Volume (IGVT)
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
Ejection Volume Variability (EVV)
Ejection Volume Variability (EVV)
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Ejection Volume Variability (EVV)
Ejection Volume Variability (EVV)
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Ejection Volume Variability (EVV)
Ejection Volume Variability (EVV)
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
Ejection Volume Variability (EVV)
v
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
Extravascular Pulmonary Water (EVW)
Extravascular Pulmonary Water (EVW)
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Extravascular Pulmonary Water (EVW)
Extravascular Pulmonary Water (EVW)
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Extravascular Pulmonary Water (EVW)
Extravascular Pulmonary Water (EVW)
Measured: After the 3rd administration of fludrocortisone or placebo (12 hours)
Extravascular Pulmonary Water (EVW)
Extravascular Pulmonary Water (EVW)
Measured: After the 4th administration of fludrocortisone or placebo (18 hours)
Mortality
Percentage of deceased patients
Measured: Day 28
Mortality
Percentage of deceased patients
Measured: Day 90
Length of stay in intensive care unit
Length of stay in intensive care unit
Measured: Day 90
Length of stay in care unit
Length of stay in care unit
Measured: Day 90
Time to wean from catecholamines
Time to wean from catecholamines
Measured: Day 90
Duration of mechanical ventilation (MV)
Duration of mechanical ventilation (MV)
Measured: Day 90
Inflammation markers
IFNγ, TNF α, IL1β, IL6, IL10 dosage
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Inflammation markers
IFNγ, TNF α, IL1β, IL6, IL10 dosage
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
natremia dosage
blood sodium
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
natremia dosage
blood sodium
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
urinary sodium dosage
urinary sodium
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
urinary sodium dosage
urinary sodium
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
kalemia dosage
blood potassium
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
kalemia dosage
blood potassium
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
urinary potassium dosage
urinary potassium
Measured: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
urinary potassium dosage
urinary potassium
Measured: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
pharmacokinetics of fludrocortisone : Area under the plasma concentration-time curve (plasma concentrations of fludrocortisone at 5 times)
in the experimental group only.
Measured: After 4th dose of fludrocortisone (18 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start31 Mar 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: study suspended until new therapeutic units are available
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- H.A.C. PHARMA
- Responsible party
- Sponsor
- Investigators
- Bruno Laviolle, MD, PhD, Study chair, Rennes University HospitalHarmonie Perrichet, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001854
- Sponsor's protocol ID
- 35RC19_8860
- Other IDs
- 2020-001430-35
- Acronym
- FLUDROSEPSIS
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2021
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT05001854
- Acronym / sponsor ID
- FLUDROSEPSIS / 35RC19_8860
- Conditions
- Septic Shock
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: study suspended until new therapeutic units are available
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- H.A.C. PHARMA
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Aug 2021 (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.
The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative adrenal insufficiency. In a previous study in healthy volunteers, we showed for the first time that fludrocortisone at a dose of 400 μg per day significantly improved the pressor response to phenylephrine. These results confirm the observations reported in rats with endotoxin shock, where fludrocortisone was shown to significantly increase blood pressure and contractile response to phenylephrine. These encouraging results argue for a potential vascular beneficial effect of fludrocortisone and need to be confirmed in a population of septic shock patients. In this context, we aimed to evaluate the effect of oral administration of 100 μg every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in septic shock patients.
Detailed description
Patients admitted to medical and surgical intensive care units with septic shock who meet the selection criteria may be offered participation in the study. The consent is signed either by the patient or his or her relative/legal representative if he or she is not capable or the patient is included according to the emergency procedure in the absence of a relative. The patient is managed according to the usual procedures for patients in septic shock. After collection of the initial workup and basal measurements, the physician randomizes (=includes) the patient into one of 2 arms : the patient receives either fludrocortisone (400 μg per day), administered in 1 dose of 100 μg every 6 hours, i.e., 2 tablets of 50 μg per dose, or the placebo
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 |
|---|---|---|
| Fludrocortisone | Experimental | Drug: Fludrocortisone100 μg every 6 hours of fludrocortisone per os A pharmacokinetic study is performed in this arm |
| Control | Placebo comparator | Drug: Placebo100 μg every 6 hours of placebo per os |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age > 18 years
- Patient with septic shock for less than 48 hours, defined by the combination of:
- Hemodynamic stability for >30 min with mean arterial pressure ≥ 65 mmHg and noradrenaline dose ≤ 0.5 μg/kg/min,
- Consent signed by the patient, family member, or legal representative or inclusion under emergency procedure,
- Negative to a diagnostic test for SARS-CoV2 less than 72 hours old; the test used must be on the the list published on the Ministry of Solidarity and Health website
Key exclusion criteria (3 listed)
- Patients under court protection will be excluded as soon as the investigator is aware of their status.
- Hemodynamic worsening with noradrenaline dose >1.5 μg/kg/min before evaluation of the primary end point.
- Catecholamine withdrawal before evaluation of the primary end point.
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: Flucortac100 μg every 6 hours of fludrocortisone per os | Drug | Fludrocortisone |
| Placebo100 μg every 6 hours of placebo per os | Drug | Control |
Primary outcome
Mean arterial blood pressure (mmHg)
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Mean arterial blood pressure (mmHg) after a dose escalation of norepinephrine in increments of 0.2 μg/kg/min to a maximum dose of 1.5 μg/kg/min.
49 secondary outcomes
Heart rate
Time frame: Baseline, before the first administration of the drug (fludrocortisone/placebo)
Heart rate
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Heart rate
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
Heart rate
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
arterial pressure
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
arterial pressure
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
arterial pressure
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
arterial pressure
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
Cardiac output
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Cardiac output
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Cardiac output
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
Cardiac output
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
Cardiac index
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Cardiac index
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Cardiac index
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
Cardiac index
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
Indexed Systemic Vascular Resistances (ISVR)
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Indexed Systemic Vascular Resistances (ISVR)
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Indexed Systemic Vascular Resistances (ISVR)
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
Indexed Systemic Vascular Resistances (ISVR)
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
Indexed Global Telediastolic Volume (IGVT)
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Indexed Global Telediastolic Volume (IGVT)
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Indexed Global Telediastolic Volume (IGVT)
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
Indexed Global Telediastolic Volume (IGVT)
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
Ejection Volume Variability (EVV)
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Ejection Volume Variability (EVV)
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Ejection Volume Variability (EVV)
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
Ejection Volume Variability (EVV)
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
Extravascular Pulmonary Water (EVW)
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Extravascular Pulmonary Water (EVW)
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Extravascular Pulmonary Water (EVW)
Time frame: After the 3rd administration of fludrocortisone or placebo (12 hours)
Extravascular Pulmonary Water (EVW)
Time frame: After the 4th administration of fludrocortisone or placebo (18 hours)
Mortality
Time frame: Day 28
Mortality
Time frame: Day 90
Length of stay in intensive care unit
Time frame: Day 90
Length of stay in care unit
Time frame: Day 90
Time to wean from catecholamines
Time frame: Day 90
Duration of mechanical ventilation (MV)
Time frame: Day 90
Inflammation markers
Time frame: Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)
Inflammation markers
Time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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. This study is not recruiting at the moment.
Bruno Laviolle, MD, PhD study chair
Rennes University Hospital
Harmonie Perrichet, MD principal investigator
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 2/3 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 18 inclusion and 3 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: paused, as of the sponsor's last update on 18 Nov 2023. 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 combined 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.
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?
Results are not available in the source record.
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?
Mean arterial blood pressure (mmHg) (time frame: 1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)). 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 18 Nov 2023.