Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury
Epis-AKI
1 other identifier
observational
10,568
14 countries
82
Brief Summary
The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedStudy Start
First participant enrolled
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedJuly 21, 2022
July 1, 2022
1.7 years
October 30, 2019
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Acute Kidney Injury
Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
72 hours after extended surgery
Secondary Outcomes (6)
Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)
72 hours after extended surgery
Number of patients with renal replacement therapy
up to 90 days after extended surgery
Mortality
up to 90 days after extended surgery
Hospital stay
up to 90 days after extended surgery (until discharge)
Intensive Care Unit stay
up to 90 days after extended surgery (until discharge)
- +1 more secondary outcomes
Study Arms (1)
Patients with extended surgical exposures
Patients with extended surgical exposures requiring postoperative observation.
Eligibility Criteria
Adult patients undergoing extended surgical procedure and the need for postoperative observation
You may qualify if:
- major elective or emergency surgery procedures with a duration of at least 2 h
- admission to the intensive care unit, intermediate care unit after surgery informed consent
You may not qualify if:
- preexisting acute kidney injury
- acute kidney injury within the last 3 months
- end stage renal disease with dialysis dependency
- kidney transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Muensterlead
- Baxter Healthcare Corporationcollaborator
Study Sites (82)
University of Alabama
Birmingham, Alabama, 35294, 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, 48165, Germany
University Hospital Muenster
Münster, D-48149, Germany
St. Josef-Stift Sendenhorst
Sendenhorst, 48324, 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, MSD-2090, 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, SI-2000, 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)
Related Publications (3)
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.
PMID: 38285051DERIVEDZarbock 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.
PMID: 37505258DERIVEDWeiss 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.
PMID: 35588372DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexander Zarbock, MD, PhD
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 18, 2019
Study Start
June 9, 2020
Primary Completion
February 28, 2022
Study Completion
March 31, 2022
Last Updated
July 21, 2022
Record last verified: 2022-07