Spontaneous Bacterial PeritonitisNCT05401721
Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
An observational study of Spontaneous Bacterial Peritonitis, run by Sohag University at 1 site in Egypt.
Trial summary
Current reports have demonstrated that copeptin predicts disease progression and prognosis in cirrhotic patients, independent of liver-specific scoring systems. To the best of our knowledge, few studies have addressed the association between copeptin and sepsis in cirrhotic patients, however, they were performed on… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Serum copeptin
- How many people
- 89 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cirrhosis and ascites
Who may be able to join
- The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of SBP will be based on the presence of at least 250 cells/ml PMNLs in the ascitic fluid, with or without positive ascitic fluid culture in the absence of hemorrhagic ascites and secondary peritonitis
Who cannot join
- Patients with heart failure, coronary insufficiency, advanced chronic respiratory disease, polyuria-polydipsia syndrome and hypotension or shock.
- Patients with chronic kidney disease treated with hemodialysis before admission.
- Patients with previous liver or kidney transplantation.
- Patients with intraabdominal malignancy.
- Patients with severe infection other than SBP.
- Patients who had received antibiotics before hospital admission.
Trial locations and contacts
1 site in 1 country.
About this study
Current reports have demonstrated that copeptin predicts disease progression and prognosis in cirrhotic patients, independent of liver-specific scoring systems. To the best of our knowledge, few studies have addressed the association between copeptin and sepsis in cirrhotic patients, however, they were performed on different types of infections. Therefore, we will conduct this study with a focus on it is possible role in patients with SBP.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Serum copeptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum copeptinDiagnostic test
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Ascites without SBP | Cirrhotic ascitic patients not diagnosed with SBP Receives: Diagnostic Test: Serum copeptin | |
| Ascites with SBP | Cirrhotic ascitic patients diagnosed with SBP Receives: Diagnostic Test: Serum copeptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare serum levels of copeptin in cirrhotic patients with and without SBP
compare serum levels of copeptin in cirrhotic patients with and without SBP
Measured: 6 months
Secondary outcomes (1)
assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function
assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 May 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abudeif Abdelaal, MD, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401721
- Sponsor's protocol ID
- Soh-Med-21-04-24
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- 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 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT05401721
- Acronym / sponsor ID
- Soh-Med-21-04-24
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 Jun 2022 (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.
Current reports have demonstrated that copeptin predicts disease progression and prognosis in cirrhotic patients, independent of liver-specific scoring systems. To the best of our knowledge, few studies have addressed the association between copeptin and sepsis in cirrhotic patients, however, they were performed on different types of infections. Therefore, we will conduct this study with a focus on it is possible role in patients with SBP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascites without SBP | – | Diagnostic Test: Serum copeptinCirrhotic ascitic patients not diagnosed with SBP |
| Ascites with SBP | – | Diagnostic Test: Serum copeptinCirrhotic ascitic patients diagnosed with SBP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis and ascites
Key inclusion criteria (1 listed)
- The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of SBP will be based on the presence of at least 250 cells/ml PMNLs in the ascitic fluid, with or without positive ascitic fluid culture in the absence of hemorrhagic ascites and secondary peritonitis
Key exclusion criteria (6 listed)
- Patients with heart failure, coronary insufficiency, advanced chronic respiratory disease, polyuria-polydipsia syndrome and hypotension or shock.
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 |
|---|---|---|
| Serum copeptinBlood test | Diagnostic test | Ascites with SBP, Ascites without SBP |
Primary outcome
compare serum levels of copeptin in cirrhotic patients with and without SBP
Time frame: 6 months
compare serum levels of copeptin in cirrhotic patients with and without SBP
1 secondary outcome
assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function
Time frame: 6 months
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 2 Jun 2022.
- 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?
An observational study of Spontaneous Bacterial Peritonitis, run by Sohag University at 1 site in Egypt.
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 1 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 2 Jun 2022. 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 Egypt. 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?
compare serum levels of copeptin in cirrhotic patients with and without SBP (time frame: 6 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 2 Jun 2022.