Cirrhotic Patients With AscitesCIRCOPEPNCT03318601
Evaluation of Copeptin in Patients With Cirrhosis and Ascites
A study testing Blood taking in people with Cirrhotic Patients With Ascites, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Copeptin is a glycopeptide released by the post-pituitary gland. In case of decrease in blood volume or blood pressure, it is secreted in the serum in an equimolar quantity to arginine vasopressin (AVP) . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhotic Patients With Ascites
- What is being tested?
- Blood taking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2016to 7 Mar 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman
- Age between 18 and 80 years
- Acute decompensation of cirrhosis with occurrence of ascites
- Hospitalisationfor a complication of cirrhosis (first occurrence of ascites or recurrent ascites requiring hospitalization, gastrointestinal bleeding, hepatic encephalopathy, etc..)
- Patients participating to Ca-DRISLA study
- Information and Consent form signed
Who cannot join
- Pregnant or breastfeeding woman
- Age minor to 18 years
- Age major to 80 years
- Adult under protection law
- outpatients hospitalized for paracentesis
- ascites not related to portal hypertension (pancreatic ascites, peritoneal carcinosis…) Patients with hepatocellular carcinoma could be included
Trial locations and contacts
1 site in 1 country.
About this study
Copeptin is a glycopeptide released by the post-pituitary gland. In case of decrease in blood volume or blood pressure, it is secreted in the serum in an equimolar quantity to arginine vasopressin (AVP) . Unlike AVP, copeptin is readily assayable in serum and its prognostic value has been recently observed during cirrhosis. However, the pathophysiological relationships between serum copeptin concentrations and indirect markers of inflammation are unknown.
The main objective of this multicenter pilot study is to study the relationship between serum copeptin and markers of inflammatory stress in cirrhotic patients with ascites. It is indeed in this population with high-risk of complications that most need biomarkers of events (like death) are needed. The main secondary objective is to evaluate the prognostic interest at 6 months of the variation of copeptin between day 0- day15.
Read the detailed description
The investigators wish to include prospectively 100 cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals. The inclusion and follow-up periods will be six months each. At the inclusion of the patients we will evaluate the correlations between the plasma concentration of copeptin and 1 / the severity of cirrhosis (Child-Pugh and MELD scores) and serum sodium; 2 / systemic inflammation markers (CRP, leukocytes, IL-6 and lipopolysaccharides), 3 / calprotectin concentration in ascites. "
- Conditions
- Cirrhotic Patients With Ascites
- Being tested
- Blood taking
- Keywords
- cirrhotic, ascite, copeptin
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood takingProcedure or surgery
Blood taking in 2 times :
- J0 : 15 mL
- J14 : 5 mL 20 mL in total volume
| Study group | Role | What they receive |
|---|---|---|
| cirrhotic patients with ascites | Experimental | cirrhotic patients with ascites requiring prolonged hospitalization Receives: Procedure: Blood taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between copetine and other biomarkers
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Measured: Day 0
Correlation between copetine and other biomarkers
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Measured: Day 7
Correlation between copetine and other biomarkers
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Measured: Day 15
Secondary outcomes (6)
Performance of CRP
ROC curve
Measured: Day 0
Performance of IL-6
ROC curve
Measured: Day 0
Performance of LPS
ROC curve
Measured: Day 0
Performance of copeptine
ROC curve
Measured: Day 0
Copetine variation
pronostic interest
Measured: Day 15
Copetine concentrations
Compared betwenn cirhotic patient and healthy volunteers
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start9 May 2016
- Primary completion13 Dec 2021
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhotic Patients With AscitesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT03318601
- Sponsor's protocol ID
- CIRCOPEP study
- Acronym
- CIRCOPEP
- Status last verified
- Jan 2025
- First submitted
- 19 Oct 2017
- Last updated
- 16 Jan 2025
- 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 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Copeptin in Patients With Cirrhosis and Ascites
- ClinicalTrials.gov ID
- NCT03318601
- Acronym / sponsor ID
- CIRCOPEP / CIRCOPEP study
- Conditions
- Cirrhotic Patients With Ascites
- Keywords
- cirrhotic, ascite, copeptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 9 May 2016 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 24 Oct 2017 (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.
Copeptin is a glycopeptide released by the post-pituitary gland. In case of decrease in blood volume or blood pressure, it is secreted in the serum in an equimolar quantity to arginine vasopressin (AVP) . Unlike AVP, copeptin is readily assayable in serum and its prognostic value has been recently observed during cirrhosis. However, the pathophysiological relationships between serum copeptin concentrations and indirect markers of inflammation are unknown.
The main objective of this multicenter pilot study is to study the relationship between serum copeptin and markers of inflammatory stress in cirrhotic patients with ascites. It is indeed in this population with high-risk of complications that most need biomarkers of events (like death) are needed. The main secondary objective is to evaluate the prognostic interest at 6 months of the variation of copeptin between day 0- day15.
Detailed description
The investigators wish to include prospectively 100 cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals. The inclusion and follow-up periods will be six months each. At the inclusion of the patients we will evaluate the correlations between the plasma concentration of copeptin and 1 / the severity of cirrhosis (Child-Pugh and MELD scores) and serum sodium; 2 / systemic inflammation markers (CRP, leukocytes, IL-6 and lipopolysaccharides), 3 / calprotectin concentration in ascites. "
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals.
| Arm | Type | Receives |
|---|---|---|
| cirrhotic patients with ascites | Experimental | Procedure: Blood takingcirrhotic patients with ascites requiring prolonged hospitalization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman
- Age between 18 and 80 years
- Acute decompensation of cirrhosis with occurrence of ascites
- Hospitalisationfor a complication of cirrhosis (first occurrence of ascites or recurrent ascites requiring hospitalization, gastrointestinal bleeding, hepatic encephalopathy, etc..)
- Patients participating to Ca-DRISLA study
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman
- Age minor to 18 years
- Age major to 80 years
- Adult under protection law
- outpatients hospitalized for paracentesis
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 |
|---|---|---|
| Blood takingBlood taking in 2 times : * J0 : 15 mL * J14 : 5 mL 20 mL in total volume | Procedure or surgery | cirrhotic patients with ascites |
Primary outcome
Correlation between copetine and other biomarkers
Time frame: Day 0
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Correlation between copetine and other biomarkers
Time frame: Day 7
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Correlation between copetine and other biomarkers
Time frame: Day 15
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
6 secondary outcomes
Performance of CRP
Time frame: Day 0
Performance of IL-6
Time frame: Day 0
Performance of LPS
Time frame: Day 0
Performance of copeptine
Time frame: Day 0
Copetine variation
Time frame: Day 15
Copetine concentrations
Time frame: Day 0
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 16 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood taking in people with Cirrhotic Patients With Ascites, run by Centre Hospitalier Universitaire de Besancon 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 6 inclusion and 6 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 16 Jan 2025. 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. 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?
Correlation between copetine and other biomarkers (time frame: Day 0). 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 16 Jan 2025.