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.
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.
Egypt1 site, 1 recruiting
- Recruiting
SOHAGU
Sohag, 28511
Ahmed Ka Osman, Resident, +201090784895, ahmed011028@med.sohag.edu.eg
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.
- Conditions
- COVID-19 Pandemic
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted14 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Karam Helmy, Sohag University
- Investigators
- Ahmed Ka Osman, Resident, Principal investigator, Sohag university-faculty of medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Liver Enzymes as a Predictor of Acute Kidney Injury in Hospitalized Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05157152
- Acronym / sponsor ID
- COVID-19 / Soh-Med-21-12-10
- Conditions
- COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 14 Dec 2021 (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.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with respirator symptoms of COVID-19 admitted at Sohag university hospital
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients whose ages >18 years old.
- Patients known to have any liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between liver enzymes and AKI in patients with COVID19
Time frame: 4 months
Elevated Liver Enzymes as a predictor of Acute Kidney Injury in hospitalized patients with COVID-19
1 secondary outcome
Severity of COVID19 infection
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Background: PubMed 34397705Ngiam 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.
- Individual participant dataSharing planned: Yes. Study protocol Methods Consent form
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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.
Ahmed Ka Osman, Resident principal investigator
Sohag university-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 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.