Acute Liver Injury in Patients With Pneumonia

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06103981
Collaborator
(none)
176
1
15.3
11.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Acute Liver Injury

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 Design

Study Type:
Observational
Anticipated Enrollment :
176 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Acute Liver Injury in Patients With Pneumonia and Its Impact on Hospital Stay and Outcome
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jan 10, 2025
Anticipated Study Completion Date :
Mar 10, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Impact of Acute liver injury due to Pneumonia [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).

Secondary Outcome Measures

  1. Patients with Pneumonia only [From Hospital admission date to Two Months]

    To evaluate the Patients with Pneumonia either developed acute liver injury or not, On Hospital Stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 68 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty Of Medicine Assuit Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beshoy Yousef Boles Abdelmalak, Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT06103981
Other Study ID Numbers:
  • Acute Liver Injury
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beshoy Yousef Boles Abdelmalak, Resident, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023