Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of Acute Kidney Injury in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406688
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Acute Kidney Injury COVID-19 ARDS

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. 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
EDTA plasma, urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Alexander Zarbock, MD +49-251-8347252 aki@anit.uni-muenster.de
Contact: Melanie Meersch, MD aki@anit.uni-muenster.de

Locations
Layout table for location information
Germany
University Hospital Münster
Münster, Germany
Sponsors and Collaborators
University Hospital Muenster
Investigators
Layout table for investigator information
Study Chair: Alexander Zarbock, MD University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Layout table for additonal information
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04406688    
Other Study ID Numbers: 04-AnIt-20
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
biomarker
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases