Prediction of Acute Kidney Injury in Patients With COVID-19

Completed

• Conditions: Acute Kidney Injury; ARDS; COVID-19

• Registration Number: NCT04406688
• Lead Sponsor: University Hospital Muenster

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.

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-28
• Study Start: 2020-06-22
• Primary Completion: 2021-12-30
• Study Completion: 2022-03-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mortality	up to 4 weeks after beginning of moderate or severe ARDS
Occurence of transient and persistent AKI	within 7 days after beginning of moderate or severe ARDS
Duration of renal replacement therapy	up to 4 weeks after beginning of moderate or severe ARDS
Duration of vasopressor administration	up to 4 weeks after beginning of moderate or severe ARDS
Duration of mechanical ventilation	up to 4 weeks after beginning of moderate or severe ARDS
Occurence of Renal replacement therapy during hospital stay	up to 4 weeks after beginning of moderate or severe ARDS
ICU length of stay	up to 4 weeks after beginning of moderate or severe ARDS
Hospital length of stay	up to 4 weeks after beginning of moderate or severe ARDS

Trial Locations

Locations (13)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario Mutua Terrassa; 🇪🇸 Terrassa, Spain

Papa Giovanni XXIII Hospital; 🇮🇹 Bergamo, Italy

San Bortolo Hospital; 🇮🇹 Vicenza, Italy

Centro Hospitalar e Universitário do Porto; 🇵🇹 Porto, Portugal

Centro Hospitalar e Universitário de Coimbra; 🇵🇹 Coimbra, Portugal

Hospital de la Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital la Fe; 🇪🇸 Valencia, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

University Hospital SAS de Jere; 🇪🇸 Jerez De La Frontera, Spain

University Hospital Münster; 🇩🇪 Münster, Germany

Hospital Germans Trias i Pujol; 🇪🇸 Barcelona, Spain

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