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NCT Number: NCT04406688

Prediction of Acute Kidney Injury in Patients With COVID-19

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate or severe ARDS according to the Berlin definition
  • SARS-CoV2 positive test
  • Age ≥ 18 years
  • Informed consent

Exclusion criteria

  • Pre-existing AKI
  • Severe CKD with eGFR<20ml/min
  • Chronic dialysis dependency
  • Kidney transplant within the last 12 months
  • Pregnancy, breastfeeding
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.

Treatment and study plan

Primary outcomes

  1. Occurence of acute kidney injury (AKI)

    Time frame: within 7 days after beginning of moderate or severe ARDS

    Occurence of moderate or severe AKI

Secondary outcomes

  1. Occurence of transient and persistent AKI

    Time frame: within 7 days after beginning of moderate or severe ARDS

  2. Occurence of Renal replacement therapy during hospital stay

    Time frame: up to 4 weeks after beginning of moderate or severe ARDS

  3. Duration of renal replacement therapy

    Time frame: up to 4 weeks after beginning of moderate or severe ARDS

  4. Mortality

    Time frame: up to 4 weeks after beginning of moderate or severe ARDS

  5. Duration of mechanical ventilation

    Time frame: up to 4 weeks after beginning of moderate or severe ARDS

  6. Duration of vasopressor administration

    Time frame: up to 4 weeks after beginning of moderate or severe ARDS

  7. ICU length of stay

    Time frame: up to 4 weeks after beginning of moderate or severe ARDS

  8. Hospital length of stay

    Time frame: up to 4 weeks after beginning of moderate or severe ARDS

Other outcomes

  1. Concentration of pro- and antiinflammatory mediators

    Time frame: within 7 days after beginning of moderate or severe ARDS

    Add-on-Analysis: Concentration of interleukin (IL) 6, IL8

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 28, 2020
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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