{bilirubin}: Bilirubin Increases the Risk of Nosocomial Infection in Cirrhotic Patients

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05752084
Collaborator
(none)
250
1
10
25

Study Details

Study Description

Brief Summary

Nosocomial infection (NIs) is a major challenge in healthcare facilities and has been associated with prolonged hospital stay as well as increased morbidity and mortality.

This research aimed to estimate the impact of acute decompensation (AD) consequences on the successive risk of nosocomial infections (NIs) and the go after outcome.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cirrhosis is the 14th most widespread cause of mortality worldwide [1], cirrhosis can take one of the following forms: compensated and decompensated phases [2]. The latter is related to subsequent complications such as ascites, hepatic encephalopathy (HE), gastrointestinal hemorrhage (GIH), jaundice, or spontaneous bacterial peritonitis (SBP) [2]. Decompensated cirrhosis is a common cause of frequent hospital admission and high fatality rate [3]. Patients with cirrhosis and decompensation have bacterial translocations (BT) and immune deterioration [4]. Therefore, they are susceptible to getting infections and septic shock [5]. On the other hand, the infection can worsen the course of cirrhosis and hasten the progression of related morbidities with a subsequent increase in death rate owing to its ability to accelerate organ failure [6]. For cirrhotic patients, the occurrence of NIs is an essential standpoint [7]. Several studies on cirrhotic patients revealed that the incidence of NIs is much higher in patients with cirrhosis and thus worsens the prognosis [8,9]. Recent studies showed that around 30 to 50% of bacterial infections (BIs) in patients with decompensated cirrhosis are NIs which is related to a higher risk of acute-chronic liver failure (ACLF), severe sepsis, and mortality [10-12].

    Nevertheless, current studies have not clarified how decompensation differentially predisposes to the occurrence of NIs and affects the outcomes. Henceforth, this study aimed to assess the incidence of NIs in cirrhosis with differential decompensation consequences, the bond between the type of decompensation at admission and the progress of NIs, and the synergism between decompensation and subsequent NIs on the outcome.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Jaundice Predisposes to the Incidence of Nosocomial Infection in Egyptian Patients With Cirrhosis: A Cohort Study
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Nov 1, 2022
    Actual Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    group 1

    the group that develops Nis during the study

    group 2

    the group doesn't develop NIs

    Outcome Measures

    Primary Outcome Measures

    1. occurrence of nosocomial infection [1 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • cirrhotic patients both sex
    Exclusion Criteria:
    • pregnancy

    • lactation

    • HCC

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Tanta Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Khadija Ahmed Mhrose Glal, assistant lecturer, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05752084
    Other Study ID Numbers:
    • TantaUu
    First Posted:
    Mar 2, 2023
    Last Update Posted:
    Mar 6, 2023
    Last Verified:
    Feb 1, 2023
    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:

    Study Results

    No Results Posted as of Mar 6, 2023