- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05074797
Epidemology of Acute Kidney Injury in Diabetic Patients Infected With covid_19 In Assiut University Hospital
October 9, 2021 updated by: Doaa Rmadan, Assiut University
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)
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: doaa DR rezk, master
- Phone Number: +20 01007749061
- Email: doaa011180@med.aun.edu.eg
Study Locations
-
-
-
Assiut, Egypt
- Doaa Ramadan Rezk
-
Contact:
- Doaa DR Ramadan, master
- Phone Number: +20 01007749061
- Email: doaa011180@med.aun.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- patients admitted because of COVID-19 infetion.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
covid not diabetic with AKI
AKI in pt with covid_19 not diabetic
|
laboratory data
|
|
AKI in covid_19 in diabetic
AKI in covid_19 in diabetic pt
|
laboratory data
|
|
covid_19 in diabetic
covid_19 in diabetic without AKI
|
laboratory data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of AKI in covid_19 in diabetic pt
Time Frame: 6 months
|
diabetic pt with AKI due to infection with covid _19
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: doaa DR rezk, master, University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2021
Primary Completion (ANTICIPATED)
February 20, 2022
Study Completion (ANTICIPATED)
March 20, 2022
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
October 9, 2021
First Posted (ACTUAL)
October 12, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 12, 2021
Last Update Submitted That Met QC Criteria
October 9, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acute kidney in covid_19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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