Prediction of Acute Kidney Injury in Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04406688|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
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.
|Condition or disease|
|Acute Kidney Injury COVID-19 ARDS|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome|
|Estimated Study Start Date :||May 25, 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||March 2021|
- Occurence of acute kidney injury (AKI) [ Time Frame: within 7 days after beginning of moderate or severe ARDS ]Occurence of moderate or severe AKI
- Occurence of transient and persistent AKI [ Time Frame: within 7 days after beginning of moderate or severe ARDS ]
- Occurence of Renal replacement therapy during hospital stay [ Time Frame: up to 4 weeks after beginning of moderate or severe ARDS ]
- Duration of renal replacement therapy [ Time Frame: up to 4 weeks after beginning of moderate or severe ARDS ]
- Mortality [ Time Frame: up to 4 weeks after beginning of moderate or severe ARDS ]
- Duration of mechanical ventilation [ Time Frame: up to 4 weeks after beginning of moderate or severe ARDS ]
- Duration of vasopressor administration [ Time Frame: up to 4 weeks after beginning of moderate or severe ARDS ]
- ICU length of stay [ Time Frame: up to 4 weeks after beginning of moderate or severe ARDS ]
- Hospital length of stay [ Time Frame: up to 4 weeks after beginning of moderate or severe ARDS ]
- Add-on analysis: pro- and antiinflammatory mediators [ Time Frame: within 7 days after beginning of moderate or severe ARDS ]e.g., Analysis of interleukin (IL) 6, IL8
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406688
|Contact: Alexander Zarbock, MDfirstname.lastname@example.org|
|Contact: Melanie Meersch, MDemail@example.com|
|University Hospital Münster|
|Study Chair:||Alexander Zarbock, MD||University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy|