Renin AngiotensinPhase 1/2AFLUCO2NCT00673270
Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression
A Phase 1/2 study testing Fludrocortisone and Hydrocortisone in people with Renin Angiotensin, 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 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renin Angiotensin
- What is being tested?
- Fludrocortisone and Hydrocortisone
- 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
- 13 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Mar 2009
- Phase
- Phase 1/2
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men between 20 and 30 years
- Body Mass Index between 18 kg/m² and 25 kg/m²
- Normal clinical examination
- Normal biological variables
- Normal electrocardiogram and echocardiography
- Written, voluntary informed consent
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- Non smoker since at least a year
- Non-inclusion Criteria:
- Any history of significant allergy
- Subjects with abnormal renal, pulmonary, cardiovascular, endocrine or hepatic function
- Medication during the study
- Alcohol consumption more than 30g/day or drug addiction
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
- Exclusion period mentioned on the Healthy Volunteers National list
- Persons deprived of freedom or under guardianship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité d'Investigation Clinique - Hôpital de Pontchaillou
Rennes, 35033
About this study
Official title: Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression
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 and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.
- Conditions
- Renin Angiotensin
- Being tested
- Fludrocortisone, Hydrocortisone, Placebo of Fludrocortisone, Placebo of Hydrocortisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludrocortisoneDrug
50 µg of fludrocortisone per os
HydrocortisoneDrug
50 mg of intravenous hydrocortisone
Placebo of FludrocortisoneDrug
Tablet of placebo of Fludrocortisone
Placebo of HydrocortisoneDrug
2 ml of isotonic saline solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fludrocortisone and Hydrocortisone Receives: Drug: Fludrocortisone; Drug: Hydrocortisone |
| 2 | Experimental | Fludrocortisone and placebo of Hydrocortisone Receives: Drug: Fludrocortisone; Drug: Placebo of Hydrocortisone |
| 3 | Experimental | Placebo of Fludrocortisone and Hydrocortisone Receives: Drug: Hydrocortisone; Drug: Placebo of Fludrocortisone |
| 4 | Placebo comparator | Placebo of Fludrocortisone and placebo of Hydrocortisone Receives: Drug: Placebo of Fludrocortisone; Drug: Placebo of Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylephrine-mean arterial pressure dose-response relationship
Measured: Between 1.5 and 3 hours after treatment
Secondary outcomes (7)
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Measured: Between administration time and 24 hours after treatment
Central aortic pressures, Augmentation Index (Aix)
Measured: Between administration time and 12 hours after treatment
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Measured: Between administration time and 12 hours after treatment
Humeral diameter and distensibility
Measured: Between administration time and 12 hours after treatment
Plasma electrolytes, blood glucose, serum creatinine
Measured: Between administration time and 24 hours after treatment
Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations
Measured: Between administration time and 24 hours after treatment
Urinary electrolytes excretion
Measured: Between administration time and 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renin AngiotensinStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 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
- NCT00673270
- Sponsor's protocol ID
- EudraCT 2007-0077969-20
- Other IDs
- CIC0203/029
- Acronym
- AFLUCO2
- Status last verified
- Mar 2012
- First submitted
- 5 May 2008
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression
- ClinicalTrials.gov ID
- NCT00673270
- Acronym / sponsor ID
- AFLUCO2 / EudraCT 2007-0077969-20
- Conditions
- Renin Angiotensin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 May 2008 (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 and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fludrocortisone, Drug: HydrocortisoneFludrocortisone and Hydrocortisone |
| 2 | Experimental | Drug: Fludrocortisone, Drug: Placebo of HydrocortisoneFludrocortisone and placebo of Hydrocortisone |
| 3 | Experimental | Drug: Hydrocortisone, Drug: Placebo of FludrocortisonePlacebo of Fludrocortisone and Hydrocortisone |
| 4 | Placebo comparator | Drug: Placebo of Fludrocortisone, Drug: Placebo of HydrocortisonePlacebo of Fludrocortisone and placebo of Hydrocortisone |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Men between 20 and 30 years
- Body Mass Index between 18 kg/m² and 25 kg/m²
- Normal clinical examination
- Normal biological variables
- Normal electrocardiogram and echocardiography
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fludrocortisone50 µg of fludrocortisone per os | Drug | 1, 2 |
| Hydrocortisone50 mg of intravenous hydrocortisone | Drug | 1, 3 |
| Placebo of FludrocortisoneTablet of placebo of Fludrocortisone | Drug | 3, 4 |
| Placebo of Hydrocortisone2 ml of isotonic saline solution | Drug | 2, 4 |
Primary outcome
Phenylephrine-mean arterial pressure dose-response relationship
Time frame: Between 1.5 and 3 hours after treatment
7 secondary outcomes
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Time frame: Between administration time and 24 hours after treatment
Central aortic pressures, Augmentation Index (Aix)
Time frame: Between administration time and 12 hours after treatment
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Time frame: Between administration time and 12 hours after treatment
Humeral diameter and distensibility
Time frame: Between administration time and 12 hours after treatment
Plasma electrolytes, blood glucose, serum creatinine
Time frame: Between administration time and 24 hours after treatment
Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations
Time frame: Between administration time and 24 hours after treatment
Urinary electrolytes excretion
Time frame: Between administration time and 24 hours after treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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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. 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 1/2 study testing Fludrocortisone and Hydrocortisone in people with Renin Angiotensin, 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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 2 Mar 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early. 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?
Phenylephrine-mean arterial pressure dose-response relationship (time frame: Between 1.5 and 3 hours after treatment). 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 Mar 2012.