Acute Kidney InjuryNCT04406688
Prediction of Acute Kidney Injury in Patients With COVID-19
An observational study of Acute Kidney Injury and COVID-19, run by University Hospital Muenster at 13 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, COVID-19, ARDS
- How many people
- 300 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 22 Jun 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Moderate or severe ARDS according to the Berlin definition
- SARS-CoV2 positive test
- Age ≥ 18 years
- Informed consent
Who cannot join
- 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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Spain7 sites
Hospital de la Vall d'Hebron
Barcelona
Hospital Germans Trias i Pujol
Barcelona
Hospital Sant Pau
Barcelona
University Hospital SAS de Jere
Jerez de la Frontera
Complejo Hospitalario de Navarra
Pamplona
Hospital Universitario Mutua Terrassa
Terrassa
Hospital la Fe
Valencia
Portugal2 sites
Centro Hospitalar e Universitário de Coimbra
Coimbra
Centro Hospitalar e Universitário do Porto
Porto
About this study
Official title: Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
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.
Read the 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.
- Conditions
- Acute Kidney Injury, COVID-19, ARDS
- Keywords
- biomarker
- Medical subject headings
- Acute Kidney Injury, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of acute kidney injury (AKI)
Occurence of moderate or severe AKI
Measured: within 7 days after beginning of moderate or severe ARDS
Secondary outcomes (8)
Occurence of transient and persistent AKI
Measured: within 7 days after beginning of moderate or severe ARDS
Occurence of Renal replacement therapy during hospital stay
Measured: up to 4 weeks after beginning of moderate or severe ARDS
Duration of renal replacement therapy
Measured: up to 4 weeks after beginning of moderate or severe ARDS
Mortality
Measured: up to 4 weeks after beginning of moderate or severe ARDS
Duration of mechanical ventilation
Measured: up to 4 weeks after beginning of moderate or severe ARDS
Duration of vasopressor administration
Measured: up to 4 weeks after beginning of moderate or severe ARDS
ICU length of stay
Measured: up to 4 weeks after beginning of moderate or severe ARDS
Hospital length of stay
Measured: up to 4 weeks after beginning of moderate or severe ARDS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start22 Jun 2020
- Primary completion30 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, MD, Study chair, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406688
- Sponsor's protocol ID
- 04-AnIt-20
- Status last verified
- Nov 2022
- First submitted
- 18 May 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weiss R, von Groote T, Ostermann M, Lumlertgul N, Weerapolchai K, Garcia MIM, Cano JMM, Del Corral BD, Broch-Porcar MJ, Perez Carrasco M, De la Vega Sanchez A, Sousa E, Catarino A, Roig AJB, Martinez de Irujo JB, de Rosa S, de la Pena MG, Tomasa T, Brivio M, De Molina FJG, Gerss J, Kellum JA, Wempe C, Leidereiter A, Meersch M, Zarbock A. The Role of Cell Cycle Arrest Biomarkers for Predicting Acute Kidney Injury in Critically Ill COVID-19 Patients: A Multicenter, Observational Study. Crit Care Med. 2023 Aug 1;51(8):992-1000. doi: 10.1097/CCM.0000000000005853. Epub 2023 Mar 28.
PubMed 36975308
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04406688
- Acronym / sponsor ID
- 04-AnIt-20
- Conditions
- Acute Kidney Injury, COVID-19, ARDS
- Keywords
- biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Moderate or severe ARDS according to the Berlin definition
- SARS-CoV2 positive test
- Age ≥ 18 years
- Informed consent
Key exclusion criteria (6 listed)
- Pre-existing AKI
- Severe CKD with eGFR<20ml/min
- Chronic dialysis dependency
- Kidney transplant within the last 12 months
- Pregnancy, breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurence of acute kidney injury (AKI)
Time frame: within 7 days after beginning of moderate or severe ARDS
Occurence of moderate or severe AKI
8 secondary outcomes
Occurence of transient and persistent AKI
Time frame: within 7 days after beginning of moderate or severe ARDS
Occurence of Renal replacement therapy during hospital stay
Time frame: up to 4 weeks after beginning of moderate or severe ARDS
Duration of renal replacement therapy
Time frame: up to 4 weeks after beginning of moderate or severe ARDS
Mortality
Time frame: up to 4 weeks after beginning of moderate or severe ARDS
Duration of mechanical ventilation
Time frame: up to 4 weeks after beginning of moderate or severe ARDS
Duration of vasopressor administration
Time frame: up to 4 weeks after beginning of moderate or severe ARDS
ICU length of stay
Time frame: up to 4 weeks after beginning of moderate or severe ARDS
Hospital length of stay
Time frame: up to 4 weeks after beginning of moderate or severe ARDS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Derived from this study: PubMed 36975308Weiss R, von Groote T, Ostermann M, Lumlertgul N, Weerapolchai K, Garcia MIM, Cano JMM, Del Corral BD, Broch-Porcar MJ, Perez Carrasco M, De la Vega Sanchez A, Sousa E, Catarino A, Roig AJB, Martinez de Irujo JB, de Rosa S, de la Pena MG, Tomasa T, Brivio M, De Molina FJG, Gerss J, Kellum JA, Wempe C, Leidereiter A, Meersch M, Zarbock A. The Role of Cell Cycle Arrest Biomarkers for Predicting Acute Kidney Injury in Critically Ill COVID-19 Patients: A Multicenter, Observational Study. Crit Care Med. 2023 Aug 1;51(8):992-1000. doi: 10.1097/CCM.0000000000005853. Epub 2023 Mar 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Zarbock, MD study chair
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and COVID-19, run by University Hospital Muenster at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, Italy, Portugal, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of acute kidney injury (AKI) (time frame: within 7 days after beginning of moderate or severe ARDS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.