Acute Liver Injury in Patients With Pneumonia

October 25, 2023 updated by: Beshoy Yousef Boles Abdelmalak, Assiut University

Acute Liver Injury in Patients With Pneumonia and Its Impact on Hospital Stay and Outcome

Acute liver injury (ALI) is defined as an acute derangement in liver function tests associated with liver-related coagulopathy, in the absence of underlying chronic liver disease.

A subset progress to acute liver failure ,Acute liver failure represent a more severe liver injury results in hepatic encephalopathy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute liver injury is associated with a spectrum of haemostatic changes, including thrombocytopenia and reduced platelet function, reduced plasma levels of many coagulation factors such as factor (F)VII and increased levels of FVIII .

Pneumonia is an acute inflammation of the lower respiratory tract. Lower respiratory tract infection is a major cause of mortality worldwide .Pneumonia is most common at the extremes of life.

In adults, pneumonia can be broadly classified, on the basis of chest radiographic appearance, into lobar pneumonia, bronchopneumonia and pneumonia producing an interstitial pattern.

There is lack of data regarding outcome and hospital stay in patients with pneumonia who develop acute liver injury.

Study Type

Observational

Enrollment (Estimated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zain Elabdeen Ahmed, Professor
  • Phone Number: 01115596820
  • Email: drzain73@yahoo.com

Study Locations

  • Egypt
      • Assuit, Egypt
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with pneumonia in hospital ward or critical care

Description

Inclusion Criteria:

  1. Patients with pneumonia that developed Acute Liver Injury
  2. Covid 19 pneumonia
  3. Patients With acute liver injury only.

Exclusion Criteria:

  1. Cancer
  2. Immunocompromised patients i.e HIV patients and patients who take immunosuppressive medications.
  3. Patients who younger than 18 yrs old
  4. pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
About 88 patients having pneumonia and developed acute liver injury That need observation of the outcome and hospital stay to evaluate acute liver injury impact
Other: Acute Liver Injury
To evaluate the impact of acute liver injury in patients with pneumonia on hospital stay and outcome.
Group B
About 88 patients having pneumonia but did not develop acute liver injury that need observation of the outcome and hospital stay
Other: Acute Liver Injury
To evaluate the impact of acute liver injury in patients with pneumonia on hospital stay and outcome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Acute liver injury due to Pneumonia
Time Frame: From Hospital admission date to Two Months
Analysis the impact of acute liver injury related to patients with pneumonia on hospital stay (measured by days spent in the hospital).
From Hospital admission date to Two Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with Pneumonia only
Time Frame: From Hospital admission date to Two Months
To evaluate the Patients with Pneumonia either developed acute liver injury or not, On Hospital Stay
From Hospital admission date to Two Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Zain Elabdeen Ahmed, Professor, Assuit Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

March 10, 2025

Study Registration Dates

First Submitted

August 12, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute Liver Injury

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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