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COVID-19 PandemicCOVID-19NCT05157152

Elevated Liver Enzymes as a Predictor of Acute Kidney Injury in Hospitalized Patients With COVID-19

An observational study of COVID-19 Pandemic, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In critically ill patients, AKI is a common complication of COVID-19 infection, occurring in 23% to 43% of cases, and was correlated with poor clinical outcomes. An increase in liver function tests ( LFTs) has been found in patients with COVID-19 ranging 14%-75% Some studies found higher levels of transaminases in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19 Pandemic
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jan 2022to 30 May 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with respirator symptoms of COVID-19 admitted at Sohag university hospital

Who may be able to join

  • Patients who are positive for COVID-19 infection in Sohag University Hospital whose ages < 18 years old. (confirmed by polymerase chain reaction (PCR) from nasopharyngeal or oropharyngeal samples) who developed AKI at time of admission or during admission.

Who cannot join

  • Patients whose ages >18 years old.
  • Patients known to have any liver disease.

Trial locations and contacts

1 site in 1 country.

Ahmed Ka Osman, Resident contact

+201090784895

ahmed011028@med.sohag.edu.eg

Egypt1 site, 1 recruiting
  • SOHAGU

    Sohag, 28511

    Ahmed Ka Osman, Resident, +201090784895, ahmed011028@med.sohag.edu.eg

    Recruiting

Other trials in Egypt

About this study

In critically ill patients, AKI is a common complication of COVID-19 infection, occurring in 23% to 43% of cases, and was correlated with poor clinical outcomes.

An increase in liver function tests ( LFTs) has been found in patients with COVID-19 ranging 14%-75% Some studies found higher levels of transaminases in patients with severe COVID-19 pneumonia and in patients dying for COVID-19.

Initial reports indicate a high incidence of abnormal liver tests and acute kidney injury (AKI) in the novel coronavirus infection (COVID-19).

We hypothesis that there is a relationship between COVID-19 patients who are critically ill, liver enzymes and level of serum creatinine

Read the detailed description

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) affects multiple organ systems and imparts significant morbidity and mortality [1]. Approximately 5% to 14% of patients affected with SARS-CoV-2 will become critically ill [2-4]. While coronavirus disease 2019 (COVID-19) generally begins as a respiratory tract infection, it can damage any organ system. Thus, to improve outcomes, clinicians should search actively for multi-organ involvement to guide appropriate early management [5].

Among affected organs, the kidney is particularly susceptible to COVID-19. Indeed, SARS-CoV-2 has been shown to share the same functional receptor, angiotensin-converting enzyme 2 (ACE2), with a wide variety of organs (such as lung, heart, kidney) [6]. SARS-CoV-2 initiates its infection process by binding to functional receptors on the membrane of a host cell. Postmortem examination of COVID-19 patients revealed varying degrees of acute tubular necrosis, lymphocytic infiltration, and viral RNA, suggesting direct invasion of kidney tubules [7]. In addition to direct kidney damage by the virus, acute kidney injury (AKI) can occur through several proposed mechanisms including acute tubular necrosis induced by sepsis, hypoxia, hypoperfusion, rhabdomyolysis, nephrotoxic drugs, etc.

In critically ill patients, AKI is a common complication of COVID-19 infection, occurring in 23% to 43% of cases, and was correlated with poor clinical outcomes. AKI was defined as per Kidney Disease Improving Global Outcomes (KDIGO) criteria: a change in the serum creatinine of 0.3 mg/dL over 48 h period or 50% increase in baseline creatinine.

An increase in liver function tests ( LFTs) has been found in patients with COVID-19 ranging 14%-75% Some studies found higher levels of transaminases in patients with severe COVID-19 pneumonia and in patients dying for COVID-19.

The clinical relevance of LFTs abnormalities has been controversial, with some studies suggesting its association with the severity of COVID-19 pneumonia, whereas others not.Some limitations affected those studies involving the lack of information about concomitant or previous use of hepatotoxic drugs among the others.

Initial reports indicate a high incidence of abnormal liver tests and acute kidney injury (AKI) in the novel coronavirus infection (COVID-19). However, outcomes in hospitalized patients with COVID-19 and elevated aspartate transaminase (AST) and alanine transaminase (ALT) levels at admission and their associations with AKI are not well understood.

Aim of the work

The aim of this study is to investigate the incidence of liver injury at admission and its contribution to the development of AKI, severity of COVID-19 and outcomes in Sohag University hospital

Patients and methods

Type of the Study:

A prospective, observational cohort study will be conducted between December 2021 and May 2022 among hospitalized COVID-19 patients in Sohag University Hospital.

Patients:

Inclusion criteria :

Patients who are positive for COVID-19 infection in Sohag University Hospital whose ages < 18 years old. (confirmed by polymerase chain reaction (PCR) from nasopharyngeal or oropharyngeal samples) who developed AKI at time of admission or during admission.

Exclusion criteria :

Patients whose ages >18 years old.

Methods A prospective, observational cohort study will be conducted between December 2021 and April 2022 among hospitalized COVID-19 patients in Sohag University Hospital.

The routine laboratory parameters will be measured before the beginning of this Study After conducting a complete physical examination.

demographic, clinical, radiological and laboratory data will be collected at admission. Information on medical history, including comorbidities, symptoms of infection and drugs taken in the previous 14 days before admission will be collected. Vital signs (respiratory rate [RR], body temperature [BT], arterial blood pressure, heart rate [HR], pulse oxygen saturation [SatO2] were collected. Laboratory tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum Albumin, Total protein, serum creatinine, Blood urea nitrogen, serum electrolytes and bilirubin were collected at admission and every 7 ± 2 days during the admission.

Patients diagnosed with COVID-19 will be divided into three groups as mild, moderate, and severe disease to evaluate the relationship between disease severity and AKI. Patients with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) plus one of the following: respiratory rate >30 breaths/min; severe respiratory distress;or SpO2 < 90% on room air will be considered as severe cases.

Patients with pneumonia and have no above severity criteria will be considered as moderate cases. Symptomatic patients without evidence of viral pneumonia or hypoxia will be considered as mild cases.

Statistical analysis :

All data will be collected and analysed using Statistical Package for Social Science ( SPSS to investigate the incidence of liver injury at admission and its contribution to the development of AKI, severity of COVID-19 and outcomes in Sohag University hospital

Ethical Consideration :

The study will be assessed by scientific and ethical committee of Sohag faculty of medicine, an informed written consent will be obtained from all patients enrolled in the study.

Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relationship between liver enzymes and AKI in patients with COVID19

    Elevated Liver Enzymes as a predictor of Acute Kidney Injury in hospitalized patients with COVID-19

    Measured: 4 months

Secondary outcomes (1)
  1. Severity of COVID19 infection

    Relationship between elevated liver enzymes and acute kidney injury as a predictor of Severity of COVID19

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 May 2022 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157152
Sponsor's protocol ID
Soh-Med-21-12-10
Acronym
COVID-19
Status last verified
Dec 2021
First submitted
12 Dec 2021
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol Methods Consent form

Publications

  • Ngiam JN, Chew N, Tham SM, Lim ZY, Li TY, Cen S, Tambyah PA, Santosa A, Muthiah M, Sia CH, Cross GB. Elevated liver enzymes in hospitalized patients with COVID-19 in Singapore. Medicine (Baltimore). 2021 Jul 30;100(30):e26719. doi: 10.1097/MD.0000000000026719.

    PubMed 34397705

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Pandemic, run by Sohag 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 2 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 14 Dec 2021. 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 Ahmed Ka Osman, Resident (+201090784895, ahmed011028@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between liver enzymes and AKI in patients with COVID19 (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157152, which also lists 1 linked publication.

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 14 Dec 2021.

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