Acute Kidney Injury Due to covid_19NCT05074797
Epidemology of Acute Kidney Injury in Diabetic Patients Infected With covid_19 In Assiut University Hospital
An observational study of Acute Kidney Injury Due to covid_19, run by Assiut University at 1 site in Egypt.
Trial summary
The novel coronavirus SARS-CoV-2 was identified as the causative agent for a series of atypical respiratory diseases in Wuhan, China in December of 2019(.1) The disease termed COVID-19, was officially declared a pandemic by the World Health Organization on March 11, 2020. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury Due to covid_19
- What is being tested?
- laboratory
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 20 Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The Data will be collected by a questionnaire includes the followings: * Socio demographic data (name, age, sex, Body weight and height, job, marital status, number of children, educational level and residence etc). * Main presenting symptoms * History of hypertension, chronic kidney disease, ect.
Who may be able to join
- patients admitted because of COVID-19 infetion.
Who cannot join
- Patients with ESRD on regular dialysis ,Patients with stage 4 or 5 non-dialysis if the condition proven to be progression of the already known diagnosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Doaa Ramadan Rezk
Asyut
Doaa DR Ramadan, master, 01007749061 ext. +20, doaa011180@med.aun.edu.eg
About this study
The novel coronavirus SARS-CoV-2 was identified as the causative agent for a series of atypical respiratory diseases in Wuhan, China in December of 2019(.1) The disease termed COVID-19, was officially declared a pandemic by the World Health Organization on March 11, 2020. SARS-CoV-2 contains a single-stranded, positive-sense RNA genome surrounded by an extracellular membrane containing a series of spike glycoproteins resembling a crown.COVID-19 infection results in diverse symptoms and morbidity depending on individual genetics, ethnicity, age, and geographic location. In severe cases, COVID-19 pathophysiology includes destruction of lung epithelial cells, thrombosis, hypercoagulation, and vascular leak leading to sepsis.(2) COVID-19 risk factors include cardiovascular disease, hypertension, and diabetes.(2)
Read the detailed description
Notably, in several studies, diabetes is one of the most reported comorbidities with poor prognosis in patients with severe COVID-19 due to Compromised innate immunity, pro-inflammatory cytokine reduced expression of ACE2 and use of renin-angiotensin-aldosterone system antagonists. (3) On the other hand, COVID-19 contributes to worsening of dysglycemia in people with diabetes mellitus by direct β-cell damage, cytokine-induced insulin resistance, hypokalemia and drugs used in the treatment of COVID-19 (like corticosteroids, lopinavir/ritonavir).(4) Nearly half of critically ill patients would develop AKI at some point during their ICU admission.(5) Acute kidney injury (AKI) has been reported to be the second observed complication in deceased patients after ARDS.it is reported that patients who died with covid19 had different degrees of AKI .The pathogenesis of kidney injury in patients infected with covid19 is multifactorial: (1) prerenal azotemia, ATN can occur owing to many contributing factors including volume depletion, cytokine storm, hypoxia, shock, or rhabdomyolysis (2) proximal tubular injury, (3) glomerulopathy, (4) thrombotic microangiopathy, and (5)complications from the treatment of COVID_19. (6)
- Conditions
- Acute Kidney Injury Due to covid_19
- Being tested
- laboratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratoryDiagnostic test
laboratory data
| Study group | Role | What they receive |
|---|---|---|
| covid not diabetic with AKI | AKI in pt with covid_19 not diabetic Receives: Diagnostic Test: laboratory | |
| AKI in covid_19 in diabetic | AKI in covid_19 in diabetic pt Receives: Diagnostic Test: laboratory | |
| covid_19 in diabetic | covid_19 in diabetic without AKI Receives: Diagnostic Test: laboratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of AKI in covid_19 in diabetic pt
diabetic pt with AKI due to infection with covid _19
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Oct 2021 (estimated)
- Primary completion20 Feb 2022 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury Due to covid_19Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Rmadan, Assiut University
- Investigators
- doaa DR rezk, master, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074797
- Sponsor's protocol ID
- Acute kidney in covid_19
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemology of Acute Kidney Injury in Diabetic Patients Infected With covid_19 In Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05074797
- Acronym / sponsor ID
- Acute kidney in covid_19
- Conditions
- Acute Kidney Injury Due to covid_19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 12 Oct 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.
The novel coronavirus SARS-CoV-2 was identified as the causative agent for a series of atypical respiratory diseases in Wuhan, China in December of 2019(.1) The disease termed COVID-19, was officially declared a pandemic by the World Health Organization on March 11, 2020. SARS-CoV-2 contains a single-stranded, positive-sense RNA genome surrounded by an extracellular membrane containing a series of spike glycoproteins resembling a crown.COVID-19 infection results in diverse symptoms and morbidity depending on individual genetics, ethnicity, age, and geographic location. In severe cases, COVID-19 pathophysiology includes destruction of lung epithelial cells, thrombosis, hypercoagulation, and vascular leak leading to sepsis.(2) COVID-19 risk factors include cardiovascular disease, hypertension, and diabetes.(2)
Detailed description
Notably, in several studies, diabetes is one of the most reported comorbidities with poor prognosis in patients with severe COVID-19 due to Compromised innate immunity, pro-inflammatory cytokine reduced expression of ACE2 and use of renin-angiotensin-aldosterone system antagonists. (3) On the other hand, COVID-19 contributes to worsening of dysglycemia in people with diabetes mellitus by direct β-cell damage, cytokine-induced insulin resistance, hypokalemia and drugs used in the treatment of COVID-19 (like corticosteroids, lopinavir/ritonavir).(4) Nearly half of critically ill patients would develop AKI at some point during their ICU admission.(5) Acute kidney injury (AKI) has been reported to be the second observed complication in deceased patients after ARDS.it is reported that patients who died with covid19 had different degrees of AKI .The pathogenesis of kidney injury in patients infected with covid19 is multifactorial: (1) prerenal azotemia, ATN can occur owing to many contributing factors including volume depletion, cytokine storm, hypoxia, shock, or rhabdomyolysis (2) proximal tubular injury, (3) glomerulopathy, (4) thrombotic microangiopathy, and (5)complications from the treatment of COVID_19. (6)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| covid not diabetic with AKI | – | Diagnostic Test: laboratoryAKI in pt with covid_19 not diabetic |
| AKI in covid_19 in diabetic | – | Diagnostic Test: laboratoryAKI in covid_19 in diabetic pt |
| covid_19 in diabetic | – | Diagnostic Test: laboratorycovid_19 in diabetic without AKI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Data will be collected by a questionnaire includes the followings: * Socio demographic data (name, age, sex, Body weight and height, job, marital status, number of children, educational level and residence etc). * Main presenting symptoms * History of hypertension, chronic kidney disease, ect.
Key inclusion criteria (1 listed)
- patients admitted because of COVID-19 infetion.
Key exclusion criteria (1 listed)
- Patients with ESRD on regular dialysis ,Patients with stage 4 or 5 non-dialysis if the condition proven to be progression of the already known diagnosis.
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 |
|---|---|---|
| laboratorylaboratory data | Diagnostic test | AKI in covid_19 in diabetic, covid not diabetic with AKI, covid_19 in diabetic |
Primary outcome
percentage of AKI in covid_19 in diabetic pt
Time frame: 6 months
diabetic pt with AKI due to infection with covid _19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: Undecided
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.
doaa DR rezk, master principal investigator
University Hospital
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 Kidney Injury Due to covid_19, 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 1 inclusion and 1 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 12 Oct 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 doaa DR rezk, master (01007749061 ext. +20, doaa011180@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of AKI in covid_19 in diabetic pt (time frame: 6 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 12 Oct 2021.