Viewing Study NCT04603664



Ignite Creation Date: 2024-05-06 @ 3:20 PM
Last Modification Date: 2024-10-26 @ 1:48 PM
Study NCT ID: NCT04603664
Status: COMPLETED
Last Update Posted: 2021-09-13
First Post: 2020-10-17

Brief Title: Role of NGAL and Cystatin C in Prediction of Acute Kidney Injury Covid-19 Infection
Sponsor: Ain Shams University
Organization: Ain Shams University

Study Overview

Official Title: Role of Neutrophil Gelatinase-Associated Lipocalin NGAL and Cystatin C in Prediction of Acute Kidney Injury in Patients With Covid-19 Infection
Status: COMPLETED
Status Verified Date: 2021-09
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: Recent different biomarkers of acute kidney injury AKI have been manufactured by pharmaceutical industry Studies proved that Neutrophil gelatinase-associated lipocalin NGAL and cystatin c are effective predictive biomarkers for early acute kidney injury in septic patients and in children after cardiopulmonary bypass This study hypothesize that both cystatin c and Neutrophil gelatinase-associated lipocalin can predict AKI in patients with COVID-19 before elevation of serum urea and creatinine which may help early interference
Detailed Description: Since December 2019 a novel coronavirus called SARSCoV-2 severe acute respiratory syndrome coronavirus 2 has caused an international outbreak of respiratory illness described as COVID-19 Among 85 patients with COVID-19 an incidence of acute kidney injury was reported to be 23 The kidney histology from autopsies of six patients showed severe acute tubular necrosis with macrophage and lymphocyte infiltration Another important paper revealed prominent acute proximal tubular injury accumulation of peritubular erythrocyte and glomerular fibrin microthrombi after autopsy However this kidney injury was not detected by routine measures creatinine andor BUN in some patients denoting subclinical kidney injury The pathophysiology of AKI associated with COVID-19 could be due to specific mechanisms such as direct cell injury from viral entrance through highly expressed renal ACE2 receptors Also pro-inflammatory cytokines an imbalanced renin-angotensin-aldosterone system and thrombotic events are accused in renal damage Non-specific mechanisms include hypovolemia haemodynamic changes right heart failure high levels of PEEP in mechanically ventilated patients nephrotoxic drugs and nosocomial infections A significant association between kidney failure and death was documented in five studies Hypoxemia and impairment of gas exchange has been identified as elements associated with AKI in patients with acute respiratory distress syndrome ARDS

Studies focusing on AKI with COVID-19 are needed urgently in order to identify the mechanism of renal affection and to predict the risk of AKI Pharmaceutical industries with academia have made a lot of progress in the field of sensitive and specific preclinical biomarkers of kidney injury Neutrophil gelatinase-associated lipocalin NGAL is composed of 178 amino acids this glycoprotein is reabsorbed in the proximal tubules after its filtration through the glomeruli

In a mouse model of renal ischemia NGAL gene was rapidly expressed and upregulated within 3 hours of injury The NGAL mRNA level increased more than 1000-fold 24-48 hours after injury Thus NGAL can be a useful tool to diagnose infection mediated AKI Nonglycosylated Cystatin C is a protein produced by nucleated cells at constant rate It is easily filtered through the glomeruli due to its positive charge at physiological pH and its low molecular weight Then it is reabsorbed and completely catabolized in the proximal tubules Use of serum cystatin C as a marker of glomerular filtration rate GFR is well documented and some authors have suggested that it may be more accurate than serum creatinine for this purpose Complete evaluation of the clinical and laboratory picture of COVID-19 associated AKI is crucial to design preventive strategies and to suggest targeted interventions

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