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Completed

NCT Number: NCT04517630

Renal Biomarkers in AKI and COVID-19

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.

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Key information

Conditions

Coronavirus Infection AKI COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS (Severe Acute Respiratory Syndrome) Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro de Investigacion en Enfermedades Infecciosas

Mexico City, 14060, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Urinary levels of renal biomarkers

    Time frame: 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 outcomes

  1. Incidence of AKI

    Time frame: One month

    Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia

  2. Urinary levels of renal biomarkers and mortality

    Time frame: 30 days

    Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality

  3. Urinary levels of renal biomarkers and severity of the disease.

    Time frame: 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.

  4. Risk factors for AKI in severe COVID-19

    Time frame: 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.

  5. Evolution renal biomarkers

    Time frame: 7 days

    Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.

  6. Evolution of viral load

    Time frame: 7 days

    Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.

  7. Evolution of complement pathway

    Time frame: 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.

  8. Metabolomic profile

    Time frame: 7 days

    Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.

  9. Respiratory changes

    Time frame: 30 days

    Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.

Other outcomes

  1. Nosocomial Infections

    Time frame: 30 days

    Stablish the nosocomial infections in subjects with or without AKI

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Enfermedades Respiratorias

Other Gov

Registry information

Official study title

Acute Kidney Injury In Subjects With Severe Acute Respiratory Syndrome Due to SARS-CoV2 Infection

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 18, 2020
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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