Renal Biomarkers in AKI and COVID-19
- Conditions
- Coronavirus InfectionCovid19AKISARS (Severe Acute Respiratory Syndrome)
- Interventions
- Diagnostic Test: urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic
- Registration Number
- NCT04517630
- Lead Sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Brief Summary
Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19.
This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.
- Detailed Description
The usefulness of urinary NGAL levels and the platelet / lymphocyte index as predictive markers of AKI in the context of COVID-19 will be studied. These results will allow to propose more appropriate strategies for the prevention, diagnosis and timely management of patients with severe pneumonia due to COVID-19 and AKI. Knowing the viral load in urine and its evolution in patients with and without AKI will allow us to explore associations between the presence of the virus at the local level and the presence of kidney damage. Likewise, the presence of viral load in urine and its possible relationship with the local activation of the complement system, together with the detection of biomarkers of kidney damage, like NGAL, TIMP-2, IGFBP7, and IL-6, will allow us to better understand the pathophysiology of these alterations in the context of COVID-19; additionally, some patients received tocilizumab, an IL-6 inhibitor as a compassionate measure, which may reduce urinary levels of interleukins and other inflammatory markers.
Finally, the study of possible differences in the metabolome in urine in patients with and without acute kidney injury could favor the discovery of new markers to identify patients with SARS-CoV-2 infection susceptible to the development of AKI.
Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic basal, and the days 3 , 5 and 7 after recruitment
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Subjects over 18 years of age.
- Subjects admitted with a diagnosis of probable SARS-CoV-2 pneumonia.
- Subjects with a diagnosis of SARS-CoV-2 pneumonia confirmed by Real-time quantitative-Polymerase Chain Reaction (qRT-PCR).
- Subjects with qRT-PCR negative for SARS-CoV-2, but who meet clinical and radiological criteria for COVID-19, and no other causes have been identified.
- Pregnant women
- Incomplete medical records.
Elimination criteria:
- Patients who die within the first 24 hours of entering the institute.
- Patients discharged for any reason not considered death within the first 48 hours, such as voluntary discharge or transfer to other health institutions.
- Patients who during their hospitalization report a positive PCR for other non-respiratory viruses without identifying SARS-CoV-2
- Patients who withdraw their consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe pneumoniae urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic Evaluate the progression to AKI during first 30 days of recruitment
- Primary Outcome Measures
Name Time Method Urinary levels of renal biomarkers Seven days To estimate the strength of association between the elevation of urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 and the development of AKI associated with SARS-CoV-2 pneumonia
- Secondary Outcome Measures
Name Time Method Risk factors for AKI in severe COVID-19 30 days Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.
Urinary levels of renal biomarkers and severity of the disease. 30 days Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.
Evolution of viral load 7 days Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.
Evolution of complement pathway seven days Analyze the complement pathway in urine and compare its evolution over time in patients with and without acute kidney injury and SARS-CoV-2 infection.
Evolution renal biomarkers 7 days Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.
Incidence of AKI One month Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia
Urinary levels of renal biomarkers and mortality 30 days Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality
Metabolomic profile 7 days Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.
Respiratory changes 30 days Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.
Trial Locations
- Locations (1)
Centro de Investigacion en Enfermedades Infecciosas
🇲🇽Mexico City, Mexico