Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis

NCT05401721 | Completed

• 1 other identifier: Soh-Med-21-04-24
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function

  6 months

Study Arms (2)

Ascites without SBP

Cirrhotic ascitic patients not diagnosed with SBP

Diagnostic Test: Serum copeptin

Ascites with SBP

Cirrhotic ascitic patients diagnosed with SBP

Diagnostic Test: Serum copeptin

Interventions

Serum copeptin DIAGNOSTIC_TEST

Blood test

Ascites with SBP; Ascites without SBP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cirrhosis and ascites

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculty of Medicine

Sohag, 82524, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 2, 2022
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)