Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury
NCT ID: NCT04165369
Last Updated: 2022-07-21
Study Results
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Basic Information
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COMPLETED
10568 participants
OBSERVATIONAL
2020-06-09
2022-03-31
Brief Summary
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The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.
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Detailed Description
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The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit (e.g., Intensive Care Unit, Intermediate Care, Post Anesthesia Care Unit) using the latest consensus definition for AKI (Kidney Disease: Improving Global Outcomes criteria) and a standardized data collection instrument and to assess the dependence of AKI on preoperative and intraoperative factors.
Method: International prospective, observational, multi-center, cross-sectional cohort study
Eligible patients will be identified during preoperative assessment. All eligible patients will be approached to obtain written consent.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with extended surgical exposures
Patients with extended surgical exposures requiring postoperative observation.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* admission to the intensive care unit, intermediate care unit after surgery informed consent
Exclusion Criteria
* acute kidney injury within the last 3 months
* end stage renal disease with dialysis dependency
* kidney transplant
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Alexander Zarbock, MD, PhD
Role: STUDY_CHAIR
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine
Locations
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University of Alabama
Birmingham, Alabama, United States
Mansoura University Hospitals
Al Mansurah, , Egypt
Alexandria University
Alexandria, , Egypt
Tanta University Faculty of Medicine
Tanta, , Egypt
CHU d'Angers
Angers, , France
Centre Hospitalier Simone Veil de Blois
Blois, , France
CHU de Bordeaux
Bordeaux, , France
Centre de Lutte contre le Cancer Francois Baclesse
Caen, , France
Hopital Privé Sévigné
Cesson-Sévigné, , France
Hopital Huriez - CHU de Lille
Lille, , France
Clinique Chénieux
Limoges, , France
Hopital Edouard Herriot
Lyon, , France
Centre Hospitalier des Pays de Morlaix
Morlaix, , France
CHU de Nices
Nice, , France
Hopital Bichat
Paris, , France
Hopital Maison Blance
Reims, , France
Clinique Sainte-Anne
Strasbourg, , France
CHG Tarbes
Tarbes, , France
Clinique Pasteur Toulouse
Toulouse, , France
Hopital Robert Schuman-Groupe UNEOS
Vantoux, , France
Gustave Roussy
Villejuif, , France
Kliniken Maria Hilf
Mönchengladbach, , Germany
Herz Jesu Krankenhaus Münster Hiltrup
Münster, , Germany
University Hospital Muenster
Münster, , Germany
St. Josef-Stift Sendenhorst
Sendenhorst, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Ospedale di Montebelluna
Montebelluna, , Italy
University of Palermo
Palermo, , Italy
Cardioanestesia - Azienda Ospedaliera San Carlo di Potenza
Potenza, , Italy
Ospedale Sant'Eugenio di Roma
Rome, , Italy
National Heart Center Tripoli
Tripoli, , Libya
Tripoli Central Hospital
Tripoli, , Libya
Mater Dei Hospital
Birkirkara, , Malta
University Clinic
Skopje, , North Macedonia
Al-Shifa Medical Complex
Gaza, , Palestinian Territories
Alia Governmental Hospital
Hebron, , Palestinian Territories
Kemerovo Cardiology Centre
Kemerovo, , Russia
Bakulev Scientific Center for Cardiovascular Surgery
Moscow, , Russia
Polenov Neurosurgical Institute
Saint Petersburg, , Russia
Almana General Hospital
Khobar, , Saudi Arabia
University Medical Centre Maribor
Ljubljana, , Slovenia
Splosna bolnisnica Murska Sobota
Murska Sobota, , Slovenia
Hospital Universitario Araba
Alava, , Spain
Hospital Universitario Funcacion Alcorcón
Alcorcón, , Spain
Urology Fundación Puigvert
Barcelona, , Spain
Donostia University Hospital
Donostia / San Sebastian, , Spain
Hospital Cliínico Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
San Pedro Hospital
Logroño, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Infanta Leonor University Hospital
Madrid, , Spain
Son Llatzer University Hospital
Palma de Mallorca, , Spain
Cukurova University
Adana, , Turkey (Türkiye)
Akdeniz University Hospital
Akdeniz, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Ibn Sina Hospital
Ankara, , Turkey (Türkiye)
Kahramanmaras Sutcu Imam University
Ankara, , Turkey (Türkiye)
Balikesir University
Balıkesir, , Turkey (Türkiye)
Uludag University
Bursa, , Turkey (Türkiye)
University of Health Sciences
Bursa, , Turkey (Türkiye)
Health Sciences University Medical School
Derince, , Turkey (Türkiye)
Düzce University
Düzce, , Turkey (Türkiye)
Gazi University Hospital
Gazi, , Turkey (Türkiye)
Acibadem MAA Ünv. Altunizade Ä'Acibadem
Istanbul, , Turkey (Türkiye)
Acibadem MAA Ünv. Atakent Acibadem
Istanbul, , Turkey (Türkiye)
Haseki Egitim Arastirma
Istanbul, , Turkey (Türkiye)
Istanbul University - Cerrahpasa
Istanbul, , Turkey (Türkiye)
Istanbul University
Istanbul, , Turkey (Türkiye)
Koc University Hospital
Istanbul, , Turkey (Türkiye)
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, , Turkey (Türkiye)
Yeditepe
Istanbul, , Turkey (Türkiye)
Dokuz Eylül Üniversitesi
Izmir, , Turkey (Türkiye)
Izmir Democracy University School of Medicine
Izmir, , Turkey (Türkiye)
Health Sciences University Kartal
Kartal, , Turkey (Türkiye)
Inönü University Hospital
Malatya, , Turkey (Türkiye)
Manisa, Medical Faculty
Manisa, , Turkey (Türkiye)
Suleyman Demirel University School of Medicine
Merkez, , Turkey (Türkiye)
Mersin University
Mersin, , Turkey (Türkiye)
Mayis University
Samsun, , Turkey (Türkiye)
Karadeniz Technical University
Trabzon, , Turkey (Türkiye)
University Faculty of Medicine
Trakya, , Turkey (Türkiye)
Countries
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References
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Meersch M, Weiss R, Strauss C, Albert F, Booke H, Forni L, Pittet JF, Kellum JA, Rosner M, Mehta R, Bellomo R, Rosenberger P, Zarbock A; EPIS-AKI Investigators. Acute kidney disease beyond day 7 after major surgery: a secondary analysis of the EPIS-AKI trial. Intensive Care Med. 2024 Feb;50(2):247-257. doi: 10.1007/s00134-023-07314-2. Epub 2024 Jan 29.
Zarbock A, Weiss R, Albert F, Rutledge K, Kellum JA, Bellomo R, Grigoryev E, Candela-Toha AM, Demir ZA, Legros V, Rosenberger P, Galan Menendez P, Garcia Alvarez M, Peng K, Leger M, Khalel W, Orhan-Sungur M, Meersch M; EPIS-AKI Investigators. Epidemiology of surgery associated acute kidney injury (EPIS-AKI): a prospective international observational multi-center clinical study. Intensive Care Med. 2023 Dec;49(12):1441-1455. doi: 10.1007/s00134-023-07169-7. Epub 2023 Jul 28.
Weiss R, Saadat-Gilani K, Kerschke L, Wempe C, Meersch M, Zarbock A; EPIS-AKI Investigators. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial. BMJ Open. 2021 Dec 30;11(12):e055705. doi: 10.1136/bmjopen-2021-055705.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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01-AnIt-19
Identifier Type: -
Identifier Source: org_study_id
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