Renal Biomarkers in AKI and COVID-19

NCT ID: NCT04517630

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-09-30

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

Conditions

Coronavirus Infection; Covid19; SARS (Severe Acute Respiratory Syndrome); AKI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Severe pneumoniae

Evaluate the progression to AKI during first 30 days of recruitment

urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic

Intervention Type: DIAGNOSTIC_TEST

Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic at basal, and the 3 , 5 and 7 days after recruitment

Interventions

urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic

Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic at basal, and the 3 , 5 and 7 days after recruitment

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Enfermedades Respiratorias

OTHER_GOV

Sponsor Role: lead

Responsible Party

Santiago Avila-Rios

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Santiago Avila Rios, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Enfermedades Respiratorias

Locations

Centro de Investigacion en Enfermedades Infecciosas

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

C26-20

Identifier Type: -

Identifier Source: org_study_id