Prediction of Acute Kidney Injury in Patients With COVID-19

NCT04406688 | Completed

• 1 other identifier: 04-AnIt-20
• Study Type: observational
• Target: 300
• Locations: 5 countries
• Sites: 13

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.

Conditions

Acute Kidney Injury; COVID-19; ARDS

Keywords

biomarker

Outcome Measures

Primary Outcomes (1)

• Occurence of acute kidney injury (AKI)

  Occurence of moderate or severe AKI

  within 7 days after beginning of moderate or severe ARDS

Secondary Outcomes (8)

• Occurence of transient and persistent AKI

  within 7 days after beginning of moderate or severe ARDS

• Occurence of Renal replacement therapy during hospital stay

  up to 4 weeks after beginning of moderate or severe ARDS

• Duration of renal replacement therapy

  up to 4 weeks after beginning of moderate or severe ARDS

• Mortality

  up to 4 weeks after beginning of moderate or severe ARDS

• Duration of mechanical ventilation

  up to 4 weeks after beginning of moderate or severe ARDS

Other Outcomes (1)

• Concentration of pro- and antiinflammatory mediators

  within 7 days after beginning of moderate or severe ARDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (13)

University Hospital Münster

Münster, Germany

Location

Papa Giovanni XXIII Hospital

Bergamo, Italy

Location

San Bortolo Hospital

Vicenza, Italy

Location

Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal

Location

Centro Hospitalar e Universitário do Porto

Porto, Portugal

Location

Hospital de la Vall d'Hebron

Barcelona, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

Hospital Sant Pau

Barcelona, Spain

Location

University Hospital SAS de Jere

Jerez de la Frontera, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Hospital Universitario Mutua Terrassa

Terrassa, Spain

Location

Hospital la Fe

Valencia, Spain

Location

Guy's & St. Thomas Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36975308 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma, urine

MeSH Terms

Conditions

Acute Kidney Injury; COVID-19

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alexander Zarbock, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 28, 2020
• Study Start: June 22, 2020
• Primary Completion: December 30, 2021
• Study Completion: March 31, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

DE (1); GB (1); PT (2); IT (2); ES (7)