Acute Liver InjuryNCT06103981
Acute Liver Injury in Patients With Pneumonia
An observational study of Acute Liver Injury and Pneumonia, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Acute Liver Injury, Pneumonia
- What is being tested?
- Acute Liver Injury
- How many people
- 176 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 10 Mar 2025
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with pneumonia in hospital ward or critical care
Who may be able to join
- Patients with pneumonia that developed Acute Liver Injury
- Covid 19 pneumonia
- Patients With acute liver injury only.
Who cannot join
- Cancer
- Immunocompromised patients i.e HIV patients and patients who take immunosuppressive medications.
- Patients who younger than 18 yrs old
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Liver Injury, Pneumonia
- Being tested
- Acute Liver Injury
- Keywords
- Acute Liver Injury, pneumonia, Covid19
- Medical subject headings
- Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Liver InjuryOther
To evaluate the impact of acute liver injury in patients with pneumonia on hospital stay and outcome.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Acute Liver Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Hospital admission date to Two Months
Secondary outcomes (1)
Patients with Pneumonia only
To evaluate the Patients with Pneumonia either developed acute liver injury or not, On Hospital Stay
Measured: From Hospital admission date to Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Yousef Boles Abdelmalak, Assiut University
- Investigators
- Zain Elabdeen Ahmed, Professor, Study chair, Assuit Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103981
- Sponsor's protocol ID
- Acute Liver Injury
- Status last verified
- Oct 2023
- First submitted
- 12 Aug 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Liver Injury in Patients With Pneumonia and Its Impact on Hospital Stay and Outcome
- ClinicalTrials.gov ID
- NCT06103981
- Acronym / sponsor ID
- Acute Liver Injury
- Conditions
- Acute Liver Injury, Pneumonia
- Keywords
- Acute Liver Injury, pneumonia, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 27 Oct 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.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Acute Liver InjuryAbout 88 patients having pneumonia and developed acute liver injury That need observation of the outcome and hospital stay to evaluate acute liver injury impact |
| Group B | – | Other: Acute Liver InjuryAbout 88 patients having pneumonia but did not develop acute liver injury that need observation of the outcome and hospital stay |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pneumonia in hospital ward or critical care
Key inclusion criteria (3 listed)
- Patients with pneumonia that developed Acute Liver Injury
- Covid 19 pneumonia
- Patients With acute liver injury only.
Key exclusion criteria (4 listed)
- Cancer
- Immunocompromised patients i.e HIV patients and patients who take immunosuppressive medications.
- Patients who younger than 18 yrs old
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Liver InjuryTo evaluate the impact of acute liver injury in patients with pneumonia on hospital stay and outcome. | Other | Group A, Group B |
Primary outcome
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).
1 secondary outcome
Patients with Pneumonia only
Time frame: From Hospital admission date to Two Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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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.
Zain Elabdeen Ahmed, Professor study chair
Assuit Faculty of Medicine
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 Acute Liver Injury and Pneumonia, run by Assiut 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beshoy Yousef, MSc (01114761284, Beshoyyoussef18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Acute liver injury due to Pneumonia (time frame: From Hospital admission date to Two 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 27 Oct 2023.