Prediction of Acute Kidney Injury in Patients With COVID-19
Status:
Not yet recruiting
Sponsors
University Hospital Muenster
Abstract:
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.
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.
Last Verified:April/30/2020
First Submitted:May/17/2020
Estimated Enrollment Submitted:May/26/2020
First Posted:May/27/2020
Last Update Submitted:May/26/2020
Last Update Posted:May/27/2020
Actual Study Start Date:May/24/2020
Estimated Primary Completion Date:January/31/2021
Estimated Study Completion Date:February/28/2021
Condition or disease:Acute Kidney Injury
COVID-19
ARDS
Phase:-
Study design:
Study Type:Observational
Observational Model:Cohort
Time Perspective:Prospective
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Sampling method:Probability Sample
Accepts Healthy Volunteers:Yes
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.

Outcome:
Primary Outcome Measures
1. Occurence of acute kidney injury (AKI) [within 7 days after beginning of moderate or severe ARDS]
Occurence of moderate or severe AKI
Secondary Outcome Measures
1. Occurence of transient and persistent AKI [within 7 days after beginning of moderate or severe ARDS]
2. Occurence of Renal replacement therapy during hospital stay [up to 4 weeks after beginning of moderate or severe ARDS]
3. Duration of renal replacement therapy [up to 4 weeks after beginning of moderate or severe ARDS]
4. Mortality [up to 4 weeks after beginning of moderate or severe ARDS]
5. Duration of mechanical ventilation [up to 4 weeks after beginning of moderate or severe ARDS]
6. Duration of vasopressor administration [up to 4 weeks after beginning of moderate or severe ARDS]
7. ICU length of stay [up to 4 weeks after beginning of moderate or severe ARDS]
8. Hospital length of stay [up to 4 weeks after beginning of moderate or severe ARDS]
Other Outcome Measures
1. Add-on analysis: pro- and antiinflammatory mediators [within 7 days after beginning of moderate or severe ARDS]
e.g., Analysis of interleukin (IL) 6, IL8
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