Renal Biomarkers in AKI and COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04517630
• Other study ID #: C26-20
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2020
• Source: Instituto Nacional de Enfermedades Respiratorias
• Contact: Santiago Ávila Ríos, PhD
• Phone: 56667985
• Email: santiago.avila[@]cieni.org.mx
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• AKI
• Coronavirus Infection
• Coronavirus Infections
• Covid19
• Infection
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Mexico	Centro de Investigacion en Enfermedades Infecciosas	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nosocomial Infections	Stablish the nosocomial infections in subjects with or without AKI	30 days
Primary	Urinary levels of renal biomarkers	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	Seven days
Secondary	Incidence of AKI	Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia	One month
Secondary	Urinary levels of renal biomarkers and mortality	Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality	30 days
Secondary	Urinary levels of renal biomarkers and severity of the disease.	Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.	30 days
Secondary	Risk factors for AKI in severe COVID-19	Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.	30 days
Secondary	Evolution renal biomarkers	Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.	7 days
Secondary	Evolution of viral load	Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.	7 days
Secondary	Evolution of complement pathway	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.	seven days
Secondary	Metabolomic profile	Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.	7 days
Secondary	Respiratory changes	Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.	30 days