Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis

• Sponsor: Sohag University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05401721
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Bacterial Peritonitis	Diagnostic Test: Serum copeptin

Study Design

• Study Type: Observational
• Actual Enrollment: 89 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
• Actual Study Start Date: May 1, 2021
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. compare serum levels of copeptin in cirrhotic patients with and without SBP [6 months]

   compare serum levels of copeptin in cirrhotic patients with and without SBP

Secondary Outcome Measures

1. assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag Faculty of Medicine	Sohag		Egypt	82524

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abudeif Abdelaal, MD, Principal investigator, Sohag University
• ClinicalTrials.gov Identifier: NCT05401721
• Other Study ID Numbers: Soh-Med-21-04-24
• First Posted: Jun 2, 2022
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peritonitis; Arginine Vasopressin

Study Results

No Results Posted as of Jun 2, 2022