Official Title
Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
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.

Completed
Acute Kidney Injury
COVID-19
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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Italy
Portugal
Spain
United Kingdom
Locations

University Hospital Münster
Münster, Germany

Papa Giovanni XXIII Hospital
Bergamo, Italy

San Bortolo Hospital
Vicenza, Italy

Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal

Centro Hospitalar e Universitário do Porto
Porto, Portugal

Hospital de la Vall d'Hebron
Barcelona, Spain

Hospital Germans Trias i Pujol
Barcelona, Spain

Hospital Sant Pau
Barcelona, Spain

University Hospital SAS de Jere
Jerez De La Frontera, Spain

Complejo Hospitalario de Navarra
Pamplona, Spain

Hospital Universitario Mutua Terrassa
Terrassa, Spain

Hospital la Fe
Valencia, Spain

Guy's & St. Thomas Hospital
London, United Kingdom

Alexander Zarbock, MD, Study Chair
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

University Hospital Muenster
NCT Number
Keywords
biomarker
MeSH Terms
COVID-19
Acute Kidney Injury
Wounds and Injuries