Rapid Diagnosis of Spontaneous Infection of Ascitic FluidCa-DRISLANCT02857101
Calprotectin for Rapid Diagnostic Infection Spontaneous of Ascites
An observational study of Rapid Diagnosis of Spontaneous Infection of Ascitic Fluid, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The determination of calprotectin in ascites, used for the diagnosis of infection of ascitic liquid, could allow the diagnosis in a very short time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Diagnosis of Spontaneous Infection of Ascitic Fluid
- What is being tested?
- dosage of calprotectin
- How many people
- 218 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Aug 2019
- Phase
- Observational
- 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
Study population: cirrhotic patients over 18 years, with ascites and hospitalized for complications of their cirrhosis: ascites decompensation first or recurrent ascites requiring prolonged hospitalization (> 2 days), gastrointestinal bleeding, encephalopathy, etc.
Who may be able to join
- Man or woman over 18 years
- Presence of ascites due to cirrhosis
- Hospitalization for a complication of cirrhosis (first or recurrent ascites ascites decompensation requiring prolonged hospitalization, gastrointestinal bleeding, encephalopathy, etc ...).
Who cannot join
- Patients with ascites admitted to the hospital for a suspected infection and receiving an antibiotic for more than 12 hours (patients with antibiotic prophylaxis with norfloxacin with a clinical suspicion of ISLA will be included in the study (there may be in this case ISLA germs resistant to quinolones).
- Outpatient hospital to perform paracentesis evacuative
- Chylous ascites,
- Hemorrhagic Ascites
- Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)
- comatose patients under guardianship or does not have all their mental faculties
Trial locations and contacts
1 site in 1 country.
Delphine WEIL-VERHOVEN, MD contact
France1 site, 1 recruiting
- Recruiting
CHRU Besançon
Besançon, 25000
Delphine WEIL-VERHOVEN, MD, dweil@chu-besancon.fr
About this study
Official title: The Ratio of Ascites Calprotectin to Total Protein is a Diagnostic and Prognostic Marker for Spontaneous Bacterial Peritonitis in Liver Cirrhosis
The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The determination of calprotectin in ascites, used for the diagnosis of infection of ascitic liquid, could allow the diagnosis in a very short time (about 30 minutes). To date, the determination of calprotectin in ascites was not evaluated properly. The investigators would thus evaluate the interest of the determination of calprotectin in ascites for the rapid diagnosis of ISLA in cirrhotic patients, like you, hospitalized for decompensation of their disease. The main purpose of this pilot study will determine the optimal threshold calprotectin in ascites for diagnosis of ISLA.
Read the detailed description
The occurrence of ascites in cirrhotic patients is a frequent event (about half of these patients developed ascites after 10 years of evolution) and marks an evolutionary turning point in the natural history of cirrhosis (30% survival at 5).
The spontaneous bacterial peritonitis (ISLA) is the leading infectious complication cirrhotic patient (prevalence of 10-30%). Half of these ISLA are already present on admission of the patient and over 20% of these infections are totally asymptomatic. The delay processing of ISLA causes heavy mortality. Even when antibiotic treatment is started immediately after the diagnosis of ISLA, in-hospital mortality remains high (about 20%) and mainly related to the development of severe sepsis, septic shock and hepatorenal syndrome; the medium-term prognosis remains severe as also survival after an episode of ISLA is 30-50% at 1 year. Therefore, the surviving patients with a first episode of ISLA are candidates for liver transplantation. Given the major prognostic implications and the asymptomatic nature of these infections, examination of ascites with neutrophil count (ANC) and bacteriological cultures still recommended during any puncture, which increases support. This is why clinicians are sensitive to processes that simplify the diagnosis of ISLA or make it faster.
The measurement of calprotectin in ascites could be of major interest for the rapid diagnosis of ISLA. It is a glycoprotein of 36 KDa fixing calcium and zinc, synthesized by neutrophils (where it represents 60% of the soluble proteins from the cytosol) as well as monocytes and macrophages in the lower concentration. It has anti-bacterial and anti-fungal, immunomodulatory and pro-apoptotic. Its synthesis is increased in case of inflammation and its rate reflects, in inflammatory bowel disease, the severity of the inflammation of the bowel wall. Fecal calprotectin allows to discriminate inflammatory bowel disease (IBD) functional impairment of the gastrointestinal tract (irritable bowel syndrome) in symptomatic patients and also seems more powerful than other non-specific markers of inflammation (CRP, sedimentation rate, leukocytosis) to make this distinction; again, this biological marker allows therapeutic monitoring for patients with IBD.
The reference technique proposed by the laboratory for assaying BÜHLMANN calprotectin is a quantitative ELISA in a stool sample or ascites but the Quantum Blue® Reader offers a faster quantitative measure (in 12 minutes). It consists of a sandwich immunoassay including the speed could be advantageously used for the diagnosis of ISLA. However, few studies have evaluated the assay of plasma calprotectin or in ascites in cirrhotic patients. A high plasma concentration of calprotectin could have a prognostic value in alcoholic cirrhosis, as a high concentration of calprotectin in ascites in decompensated cirrhosis.
- Being tested
- dosage of calprotectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosage of calprotectinOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the calprotectin level in ascitic fluid with Quantum Blue® Reader
Establish an optimal threshold calprotectin in ascites for diagnosis of ISLA and evaluate the performance of calprotectin in ascites in cirrhotic patients with ascites due to portal hypertension only.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Diagnosis of Spontaneous Infection of Ascitic FluidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Bühlmann Laboratories AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857101
- Sponsor's protocol ID
- P/2015/243
- Acronym
- Ca-DRISLA
- Status last verified
- Jul 2018
- First submitted
- 28 Jul 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ratio of Ascites Calprotectin to Total Protein is a Diagnostic and Prognostic Marker for Spontaneous Bacterial Peritonitis in Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02857101
- Acronym / sponsor ID
- Ca-DRISLA / P/2015/243
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Bühlmann Laboratories AG
- Study start
- Feb 2015
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 5 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.
The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The determination of calprotectin in ascites, used for the diagnosis of infection of ascitic liquid, could allow the diagnosis in a very short time (about 30 minutes). To date, the determination of calprotectin in ascites was not evaluated properly. The investigators would thus evaluate the interest of the determination of calprotectin in ascites for the rapid diagnosis of ISLA in cirrhotic patients, like you, hospitalized for decompensation of their disease. The main purpose of this pilot study will determine the optimal threshold calprotectin in ascites for diagnosis of ISLA.
Detailed description
The occurrence of ascites in cirrhotic patients is a frequent event (about half of these patients developed ascites after 10 years of evolution) and marks an evolutionary turning point in the natural history of cirrhosis (30% survival at 5).
The spontaneous bacterial peritonitis (ISLA) is the leading infectious complication cirrhotic patient (prevalence of 10-30%). Half of these ISLA are already present on admission of the patient and over 20% of these infections are totally asymptomatic. The delay processing of ISLA causes heavy mortality. Even when antibiotic treatment is started immediately after the diagnosis of ISLA, in-hospital mortality remains high (about 20%) and mainly related to the development of severe sepsis, septic shock and hepatorenal syndrome; the medium-term prognosis remains severe as also survival after an episode of ISLA is 30-50% at 1 year. Therefore, the surviving patients with a first episode of ISLA are candidates for liver transplantation. Given the major prognostic implications and the asymptomatic nature of these infections, examination of ascites with neutrophil count (ANC) and bacteriological cultures still recommended during any puncture, which increases support. This is why clinicians are sensitive to processes that simplify the diagnosis of ISLA or make it faster.
The measurement of calprotectin in ascites could be of major interest for the rapid diagnosis of ISLA. It is a glycoprotein of 36 KDa fixing calcium and zinc, synthesized by neutrophils (where it represents 60% of the soluble proteins from the cytosol) as well as monocytes and macrophages in the lower concentration. It has anti-bacterial and anti-fungal, immunomodulatory and pro-apoptotic. Its synthesis is increased in case of inflammation and its rate reflects, in inflammatory bowel disease, the severity of the inflammation of the bowel wall. Fecal calprotectin allows to discriminate inflammatory bowel disease (IBD) functional impairment of the gastrointestinal tract (irritable bowel syndrome) in symptomatic patients and also seems more powerful than other non-specific markers of inflammation (CRP, sedimentation rate, leukocytosis) to make this distinction; again, this biological marker allows therapeutic monitoring for patients with IBD.
The reference technique proposed by the laboratory for assaying BÜHLMANN calprotectin is a quantitative ELISA in a stool sample or ascites but the Quantum Blue® Reader offers a faster quantitative measure (in 12 minutes). It consists of a sandwich immunoassay including the speed could be advantageously used for the diagnosis of ISLA. However, few studies have evaluated the assay of plasma calprotectin or in ascites in cirrhotic patients. A high plasma concentration of calprotectin could have a prognostic value in alcoholic cirrhosis, as a high concentration of calprotectin in ascites in decompensated cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cirrhotic patients over 18 years, with ascites and hospitalized for complications of their cirrhosis: ascites decompensation first or recurrent ascites requiring prolonged hospitalization (> 2 days), gastrointestinal bleeding, encephalopathy, etc.
Key inclusion criteria (3 listed)
- Man or woman over 18 years
- Presence of ascites due to cirrhosis
- Hospitalization for a complication of cirrhosis (first or recurrent ascites ascites decompensation requiring prolonged hospitalization, gastrointestinal bleeding, encephalopathy, etc ...).
Key exclusion criteria (6 listed)
- Patients with ascites admitted to the hospital for a suspected infection and receiving an antibiotic for more than 12 hours (patients with antibiotic prophylaxis with norfloxacin with a clinical suspicion of ISLA will be included in the study (there may be in this case ISLA germs resistant to quinolones).
- Outpatient hospital to perform paracentesis evacuative
- Chylous ascites,
- Hemorrhagic Ascites
- Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)
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 |
|---|---|---|
| dosage of calprotectin | Other | – |
Primary outcome
Measurement of the calprotectin level in ascitic fluid with Quantum Blue® Reader
Time frame: 18 months
Establish an optimal threshold calprotectin in ascites for diagnosis of ISLA and evaluate the performance of calprotectin in ascites in cirrhotic patients with ascites due to portal hypertension only.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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.
Delphine WEIL-VERHOVEN, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Diagnosis of Spontaneous Infection of Ascitic Fluid, 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 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delphine WEIL-VERHOVEN, MD (dweil@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the calprotectin level in ascitic fluid with Quantum Blue® Reader (time frame: 18 months). 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 Jul 2018.