Clinical trial NCT04406688: Prediction of Acute Kidney Injury in Patients With COVID-19
Official title: Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
COVID-19
ARDS
Keywords: biomarker
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)" and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage. However, no data are available whether these parameters can also predict the occurrence of AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the optimisation of therapeutic management to improve patient outcome and for the triage of patients.

The aim of this observational study is to evaluate whether the biomarker \[TIMP- 2\]\*\[IGFBP7\] can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2 associated acute respiratory distress syndrome.

Detailed description: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is rapidly spreading around the world. The current outbreak of infections with SARS-CoV-2 is termed Coronavirus Disease 2019 (COVID-19). Two other coronavirus infections, SARS in 2002-2003 and Middle East Respiratory Syndrome (MERS) in 2012, both caused severe respiratory syndrome in humans. All 3 of these emerging infectious diseases are caused by β-coronaviruses.

Although COVID-19 primarily affects the lungs and may cause severe hypoxemia, other organs including the GI tract, heart and kidney are affected. Acute kidney injury secondary to COVID-19 (COV-AKI) is reported to occur in about 15-25% of patients hospitalized with COVID-19 infection. The majority of AKI cases are mild to moderate with renal replacement requirement in about 25%. However, AKI was much more common in non-survivors (\>50%). Although kidney failure appears to occur late in the course, patients may begin to develop AKI within the first 3 days of hospitalization. Similar to AKI in other settings,3 COV-AKI is likely to be of variable etiology. Thus, there may be a long window for treatment.

The two cell-cycle arrest markers, tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth-factor binding protein 7 (IGFBP7), have been shown to early predict the occurrence of AKI in cardiac surgical and critically ill patients. However, there is no data available whether (TIMP-2)\*(IGFBP7) can predict the occurrence of AKI in the COVID19 setting. Early prediction of AKI may be valuable to optimize therapeutic management in order to improve patient's outcome and might be helpful to triage patients.

The goal of this observational trial is to evaluate whether (TIMP-2)\*(IGFBP7) early predicts the occurrence of AKI in critically ill patients with SARS-CoV2 associated ARDS.

Eligibility criteria: Inclusion Criteria:

1. Moderate or severe ARDS according to the Berlin definition
2. SARS-CoV2 positive test
3. Age ≥ 18 years
4. Informed consent

Exclusion Criteria:

1. Pre-existing AKI
2. Severe CKD with eGFR\<20ml/min
3. Chronic dialysis dependency
4. Kidney transplant within the last 12 months
5. Pregnancy, breastfeeding
6. Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.

Primary outcomes:
measure: Occurence of acute kidney injury (AKI)
timeFrame: within 7 days after beginning of moderate or severe ARDS
Secondary outcomes:
measure: Occurence of transient and persistent AKI
timeFrame: within 7 days after beginning of moderate or severe ARDS
measure: Occurence of Renal replacement therapy during hospital stay
timeFrame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Duration of renal replacement therapy
timeFrame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Mortality
timeFrame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Duration of mechanical ventilation
timeFrame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Duration of vasopressor administration
timeFrame: up to 4 weeks after beginning of moderate or severe ARDS
measure: ICU length of stay
timeFrame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Hospital length of stay
timeFrame: up to 4 weeks after beginning of moderate or severe ARDS
Other outcomes:
measure: Concentration of pro- and antiinflammatory mediators
timeFrame: within 7 days after beginning of moderate or severe ARDS
Locations:
city: Münster
country: Germany
facility: University Hospital Münster
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Hospital
city: Vicenza
country: Italy
facility: San Bortolo Hospital
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
city: Porto
country: Portugal
facility: Centro Hospitalar e Universitário do Porto
city: Barcelona
country: Spain
facility: Hospital de la Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Jerez De La Frontera
country: Spain
facility: University Hospital SAS de Jere
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua Terrassa
city: Valencia
country: Spain
facility: Hospital la Fe
city: London
country: United Kingdom
facility: Guy's & St. Thomas Hospital
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy
name: Alexander Zarbock, MD
role: STUDY_CHAIR
References: