Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis

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 Overview

• Status: Completed
• Conditions: Spontaneous Bacterial Peritonitis
• Intervention / Treatment: Diagnostic test: Serum copeptin

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cirrhosis and ascites

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ascites without SBP; Cirrhotic ascitic patients not diagnosed with SBP	Diagnostic test: Serum copeptin; Blood test
Ascites with SBP; Cirrhotic ascitic patients diagnosed with SBP	Diagnostic test: Serum copeptin; Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Arginine Vasopressin
• Other Study ID Numbers: Soh-Med-21-04-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No