Prediction of Acute Kidney Injury in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406688
• Other study ID #: 04-AnIt-20
• Status: Completed
• Start date: June 22, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 31, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• ARDS
• COVID-19
• Wounds and Injuries

Locations

Country	Name	City	State
Germany	University Hospital Münster	Münster
Italy	Papa Giovanni XXIII Hospital	Bergamo
Italy	San Bortolo Hospital	Vicenza
Portugal	Centro Hospitalar e Universitário de Coimbra	Coimbra
Portugal	Centro Hospitalar e Universitário do Porto	Porto
Spain	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
United Kingdom	Guy's & St. Thomas Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Countries where clinical trial is conducted

Germany,  Italy,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of pro- and antiinflammatory mediators	Add-on-Analysis: Concentration of interleukin (IL) 6, IL8	within 7 days after beginning of moderate or severe ARDS
Primary	Occurence of acute kidney injury (AKI)	Occurence of moderate or severe AKI	within 7 days after beginning of moderate or severe ARDS
Secondary	Occurence of transient and persistent AKI		within 7 days after beginning of moderate or severe ARDS
Secondary	Occurence of Renal replacement therapy during hospital stay		up to 4 weeks after beginning of moderate or severe ARDS
Secondary	Duration of renal replacement therapy		up to 4 weeks after beginning of moderate or severe ARDS
Secondary	Mortality		up to 4 weeks after beginning of moderate or severe ARDS
Secondary	Duration of mechanical ventilation		up to 4 weeks after beginning of moderate or severe ARDS
Secondary	Duration of vasopressor administration		up to 4 weeks after beginning of moderate or severe ARDS
Secondary	ICU length of stay		up to 4 weeks after beginning of moderate or severe ARDS
Secondary	Hospital length of stay		up to 4 weeks after beginning of moderate or severe ARDS