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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05752084
Other study ID # TantaUu
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date November 1, 2022

Study information

Verified date February 2023
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date November 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - cirrhotic patients both sex Exclusion Criteria: - pregnancy - lactation - HCC

Study Design


Locations

Country Name City State
Egypt Tanta University Tanta

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary occurrence of nosocomial infection 1 months
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