Acute HepatitisCORT-HEPATNCT02859584
ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS
A study testing Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL in people with Acute Hepatitis, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of decreased cortisol-binding proteins on STC, serum… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Hepatitis
- What is being tested?
- Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Feb 2014
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion of 101 test subjects and for statistical analysis:
- 29 patients with non-acute severe hepatitis (TP> 50% and AST or ALT> 500 IU / L or> 10 xN for less than 15 days).
- 43 patients with severe acute hepatitis (TP <50%). Patients with suspected IS with the assay of the CTS will retested at Synacthène 4 to 6 months later (10 desired subjects).
- 29 healthy volunteers (control group included in the analysis).
- Inclusion of 10 patients with established IS (control group to estimate the low values of cortisol).
- Patient who signed the consent of study participation
Who cannot join
- Women during pregnancy or breastfeeding
- Minor and over 75 years
- Major protected within the meaning of Huriet
- Subject healthy volunteers in a sport competition
- Patients transplanted, HIV infection (also refusing HIV status) or patients on immunosuppressive therapies (including corticosteroids)
- ketoconazole Shot, rifampicin, mifepristone, megestrol or etomidate
Show all 16Show fewer
- Treatment with corticosteroids irrespective of the route of administration
- severe acute alcoholic hepatitis
- oral fungal infection
- upper gastrointestinal bleeding or oral bleeding (contamination salivettes)
- unbalanced Diabetes
- unbalanced Hypertension
- Chronic heart failure (stage III or IV of the classification of the New York Heart Association [NYHA])
- Inability to receive clear information in patients with severe encephalopathy and do not have someone you trust
- Refusal of the participation agreement by signing the form of information and consent as defined in the protocol.
- Septic shock
About this study
Official title: ASSESSMENT OF ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS USING CONCENTRATION OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol (SalivCort) in SAH.
Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were measured
Read the detailed description
We prospectively and consecutively enrolled 75 patients suffering from a SAH (n=44) or a NSAH (n=31). Inclusion criteria were patients aged between 18 and 75 years with an acute hepatitis defined by an abrupt rise in serum aminotransaminase levels during the 15 previous days (AST or ALT greater than 500 IU/L or greater than 10 times the upper normal value); the acute hepatitis was considered as severe if the prothrombin index was lower than 50% and as non-severe if it was greater than 50%. We excluded patients with the following conditions: a history of hypothalamic-pituitary or adrenal disease, corticosteroids treatment within the previous 6 months, ketoconazole intake, oral candida infection, any visible bleeding in the oral cavity, liver transplanted patients, acute alcoholic hepatitis and night workers. Twenty-nine healthy controls (HC) were thereafter enrolled and similarly distributed with the SAH group on age, sex and estrogen pill intake, estrogen therapy being the most common cause for changes in CBG levels. HC were without any known illnesses and were not receiving any medications. To evaluate the range of the SFC concentrations, eight patients with a known AD caused by impairment of hypothalamic-pituitary-adrenal axis (n=5) and adrenal gland (n=3) and followed at the Endocrinology Department of Besancon were also studied.
STC, SFC and salivary cortisol concentrations were measured blindly before (T0 between 8am and 9am) and 60 minutes after (T60) an intravenous injection of 250 µg tetracosactrin (synacthenÒ, Sigma-Tau laboratory, France). Serum CBG, albumin and ACTH were also measured
- Conditions
- Acute Hepatitis
- Being tested
- Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
- Keywords
- Acute hepatitis, acute liver failure, adrenal dysfunction, salivary cortisol, serum free cortisol
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOLBiological
| Study group | Role | What they receive |
|---|---|---|
| no serious acute hepatitis | Other | Not described Receives: Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
| Serious acute hepatitis | Other | Not described Receives: Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
| Healthy volunteers | Other | Not described Receives: Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
| Surrenal insufficiency | Other | Not described Receives: Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of the serum total cortisol (STC) in SAH.
Measured: 2 years
Concentration of the serum free cortisol (SFC) in SAH.
Measured: 2 years
Concentration of the salivary cortisol (SalivCort) in SAH.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HepatitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859584
- Sponsor's protocol ID
- 2011-A00385-36
- Acronym
- CORT-HEPAT
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS USING CONCENTRATION OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
- ClinicalTrials.gov ID
- NCT02859584
- Acronym / sponsor ID
- CORT-HEPAT / 2011-A00385-36
- Conditions
- Acute Hepatitis
- Keywords
- Acute hepatitis, acute liver failure, adrenal dysfunction, salivary cortisol, serum free cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Aug 2016 (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.
A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol (SalivCort) in SAH.
Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were measured
Detailed description
We prospectively and consecutively enrolled 75 patients suffering from a SAH (n=44) or a NSAH (n=31). Inclusion criteria were patients aged between 18 and 75 years with an acute hepatitis defined by an abrupt rise in serum aminotransaminase levels during the 15 previous days (AST or ALT greater than 500 IU/L or greater than 10 times the upper normal value); the acute hepatitis was considered as severe if the prothrombin index was lower than 50% and as non-severe if it was greater than 50%. We excluded patients with the following conditions: a history of hypothalamic-pituitary or adrenal disease, corticosteroids treatment within the previous 6 months, ketoconazole intake, oral candida infection, any visible bleeding in the oral cavity, liver transplanted patients, acute alcoholic hepatitis and night workers. Twenty-nine healthy controls (HC) were thereafter enrolled and similarly distributed with the SAH group on age, sex and estrogen pill intake, estrogen therapy being the most common cause for changes in CBG levels. HC were without any known illnesses and were not receiving any medications. To evaluate the range of the SFC concentrations, eight patients with a known AD caused by impairment of hypothalamic-pituitary-adrenal axis (n=5) and adrenal gland (n=3) and followed at the Endocrinology Department of Besancon were also studied.
STC, SFC and salivary cortisol concentrations were measured blindly before (T0 between 8am and 9am) and 60 minutes after (T60) an intravenous injection of 250 µg tetracosactrin (synacthenÒ, Sigma-Tau laboratory, France). Serum CBG, albumin and ACTH were also measured
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no serious acute hepatitis | Other | Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
| Serious acute hepatitis | Other | Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
| Healthy volunteers | Other | Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
| Surrenal insufficiency | Other | Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inclusion of 101 test subjects and for statistical analysis:
- Inclusion of 10 patients with established IS (control group to estimate the low values of cortisol).
- Patient who signed the consent of study participation
Key exclusion criteria (16 listed)
- Women during pregnancy or breastfeeding
- Minor and over 75 years
- Major protected within the meaning of Huriet
- Subject healthy volunteers in a sport competition
- Patients transplanted, HIV infection (also refusing HIV status) or patients on immunosuppressive therapies (including corticosteroids)
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 |
|---|---|---|
| Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL | Biological | Healthy volunteers, Serious acute hepatitis, Surrenal insufficiency, no serious acute hepatitis |
Primary outcome
Concentration of the serum total cortisol (STC) in SAH.
Time frame: 2 years
Concentration of the serum free cortisol (SFC) in SAH.
Time frame: 2 years
Concentration of the salivary cortisol (SalivCort) in SAH.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- articleLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL in people with Acute Hepatitis, run by Centre Hospitalier Universitaire de Besancon.
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 16 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: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of the serum total cortisol (STC) in SAH. (time frame: 2 years). 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 19 Aug 2016.