NCT06103981

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

August 12, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

Acute Liver InjurypneumoniaCovid19

Outcome Measures

Primary Outcomes (1)

  • Impact of Acute liver injury due to Pneumonia

    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 Outcomes (1)

  • Patients with Pneumonia only

    From Hospital admission date to Two Months

Study Arms (2)

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

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

Interventions

To evaluate the impact of acute liver injury in patients with pneumonia on hospital stay and outcome.

Group AGroup B

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with pneumonia in hospital ward or critical care

You may qualify if:

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

You may not qualify if:

  • Cancer
  • Immunocompromised patients i.e HIV patients and patients who take immunosuppressive medications.
  • Patients who younger than 18 yrs old
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

PneumoniaCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPneumonia, ViralVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Zain Elabdeen Ahmed, Professor

    Assuit Faculty of Medicine

    STUDY CHAIR

Central Study Contacts

Beshoy Yousef, MSc

CONTACT

Zain Elabdeen Ahmed, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 12, 2023

First Posted

October 27, 2023

Study Start

December 1, 2023

Primary Completion

January 10, 2025

Study Completion

March 10, 2025

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations