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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05401721
Other study ID # Soh-Med-21-04-24
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 1, 2021

Study information

Verified date May 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 different types of infections. Therefore, we will conduct this study with a focus on it is possible role in patients with SBP.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Serum copeptin
Blood test

Locations

Country Name City State
Egypt Sohag Faculty of Medicine Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary compare serum levels of copeptin in cirrhotic patients with and without SBP compare serum levels of copeptin in cirrhotic patients with and without SBP 6 months
Secondary 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 6 months
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