Prediction of Acute Kidney Injury in Patients With COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-22

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)

NCT04393428

COVID-19 Renal Replacement Therapy Acute Kidney Injury

COMPLETED

AKI Biomarkers in Coronavirus(COVID)-19

NCT04408248

COVID Acute Respiratory Failure Acute Kidney Injury

UNKNOWN

Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection

NCT04491227

Covid19 AKI CKD +2 more

UNKNOWN

Acute Kidney Dysfunction in COVID-19 and Non-COVID-19 Related ARDS

NCT05699889

COVID-19 Acute Respiratory Distress Syndrome Acute Kidney Injury Due to COVID-19

COMPLETED

Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Septic AKI

NCT06064487

AKI - Acute Kidney Injury

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury COVID-19 ARDS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No