Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444893
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-03
Brief Title:
Morphofunctional Gene Inflammation Molecules and Oxidative Stress Analysis in Kidney Tissue of COVID-19 Patients
Sponsor:
Instituto Nacional de Enfermedades Respiratorias
Organization:
Instituto Nacional de Enfermedades Respiratorias
Study Overview
Official Title:
Morphofunctional Analysis Gene Expression of Inflammation Molecules and Response Mechanisms to Oxidative Stress in Kidney Tissue of Deceased Patients With COVID-19 Ancestral Variant
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The involvement of the kidneys in patients infected with the severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 at the outset of the pandemic was associated with high mortality rates worldwide This was in part due to the generation of an inflammatory process and exacerbated oxidative stress The present study was initiated to investigate the relationship between morphofunctional changes and gene expression in the kidney tissue of deceased Mexican patients prior to the initiation of vaccination
The investigator designed a single-center prospective cohort study to analyze and relate the morphofunctional changes and gene expression of inflammatory and oxidative stress molecules in the kidney tissue of men who died from severe COVID-19 A total of 40 percutaneous renal biopsies from deceased patients with severe acute respiratory syndrome coronavirus 2 infection were included in the study and divided into two a groups One group was preserved in trizol to obtain RNA and total protein while the remaining sample was fixed in formalin to be examined by staining with hematoxylin and eosin The histopathological analysis was conducted by an experienced pathologist The expression of molecules was evaluated by real-time polymerase chain reaction assay nphs2 slc9a1 cx3cl1 havcr1 slc22a17 sod2 egf timp2 hmox1 fabp1 and so forth The following biomarkers were analyzed interleukin-6 Arginase-1 Arg-1 Dipeptidyl peptidase-4 DPP-4 GSTT1 type I gamma-glutamyltransferase GGT1 Occludin OCL CYP3A4 and Claudin-8 CL-8 Additionally Western blot analysis was conducted on claudin-5 CL-5 occludin HSP70 Nuclear factor erythroid 2-related factor-2 NRF-2 superoxide dismutase-2 SOD-2 nicotinamide adenine dinucleotide phosphate dehydrogenase 1 NQO1 Gamma glutamylcysteine synthase γ-GCL and receptor for advanced glycation end products RAGE The estimated glomerular filtration rate eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration CKD-EPI equation with the subjects divided into two groups based on their eGFR 60 or 60 mlmin173 m² The statistical analysis was conducted using the Stata program and GraphPad software version 1023
The investigator designed a single-center prospective cohort study to analyze and relate the morphofunctional changes and gene expression of inflammatory and oxidative stress molecules in the kidney tissue of men who died from severe COVID-19 A total of 40 percutaneous renal biopsies from deceased patients with severe acute respiratory syndrome coronavirus 2 infection were included in the study and divided into two a groups One group was preserved in trizol to obtain RNA and total protein while the remaining sample was fixed in formalin to be examined by staining with hematoxylin and eosin The histopathological analysis was conducted by an experienced pathologist The expression of molecules was evaluated by real-time polymerase chain reaction assay nphs2 slc9a1 cx3cl1 havcr1 slc22a17 sod2 egf timp2 hmox1 fabp1 and so forth The following biomarkers were analyzed interleukin-6 Arginase-1 Arg-1 Dipeptidyl peptidase-4 DPP-4 GSTT1 type I gamma-glutamyltransferase GGT1 Occludin OCL CYP3A4 and Claudin-8 CL-8 Additionally Western blot analysis was conducted on claudin-5 CL-5 occludin HSP70 Nuclear factor erythroid 2-related factor-2 NRF-2 superoxide dismutase-2 SOD-2 nicotinamide adenine dinucleotide phosphate dehydrogenase 1 NQO1 Gamma glutamylcysteine synthase γ-GCL and receptor for advanced glycation end products RAGE The estimated glomerular filtration rate eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration CKD-EPI equation with the subjects divided into two groups based on their eGFR 60 or 60 mlmin173 m² The statistical analysis was conducted using the Stata program and GraphPad software version 1023
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None