Nosocomial Infection{bilirubin}NCT05752084
Bilirubin Increases the Risk of Nosocomial Infection in Cirrhotic Patients
An observational study of Nosocomial Infection, run by Tanta University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nosocomial Infection
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients were diagnosed with cirrhosis based on liver biopsy. Decompensation was defined as acute deterioration in liver function accompanied with acute onset of complications such as ascites, HE, GIH, BIs, or jaundice at the time of hospitalization
Who may be able to join
- cirrhotic patients both sex
Who cannot join
- pregnancy
- lactation
- HCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Jaundice Predisposes to the Incidence of Nosocomial Infection in Egyptian Patients With Cirrhosis: A Cohort Study
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.
Read the 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.
- Conditions
- Nosocomial Infection
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | the group that develops Nis during the study | |
| group 2 | the group doesn't develop NIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of nosocomial infection
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Jan 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Ahmed Mhrose Glal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752084
- Sponsor's protocol ID
- Nosocomial Infection
- Acronym
- {bilirubin}
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jaundice Predisposes to the Incidence of Nosocomial Infection in Egyptian Patients With Cirrhosis: A Cohort Study
- ClinicalTrials.gov ID
- NCT05752084
- Acronym / sponsor ID
- {bilirubin} / Nosocomial Infection
- Conditions
- Nosocomial Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –the group that develops Nis during the study |
| group 2 | – | –the group doesn't develop NIs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients were diagnosed with cirrhosis based on liver biopsy. Decompensation was defined as acute deterioration in liver function accompanied with acute onset of complications such as ascites, HE, GIH, BIs, or jaundice at the time of hospitalization
Key inclusion criteria (1 listed)
- cirrhotic patients both sex
Key exclusion criteria (3 listed)
- pregnancy
- lactation
- HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of nosocomial infection
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Infection, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of nosocomial infection (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.