Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury
- Conditions
- Acute Kidney Injury (AKI)
- Registration Number
- NCT04165369
- Lead Sponsor
- University Hospital Muenster
- 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.
- Detailed Description
Acute kidney injury (AKI) is a severe clinical complication with increasing incidence and is associated with adverse short- and long-term outcomes resulting in a major health care burden worldwide. The introduction of consensus classification systems has enhanced the awareness for AKI. 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. However, analyzing AKI from existing databases is often limited by missing data elements, especially the inclusion of the urine output criteria. Missing data and the use of different definitions before the consensus classification are the reasons for large variations in reported occurrences of surgical induced AKI.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10568
- 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
- preexisting acute kidney injury
- acute kidney injury within the last 3 months
- end stage renal disease with dialysis dependency
- kidney transplant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Acute Kidney Injury 72 hours after extended surgery Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
- Secondary Outcome Measures
Name Time Method Number of patients with renal replacement therapy up to 90 days after extended surgery Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3) 72 hours after extended surgery Definition and classification of acute injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guidelines on acute kidney injury
Mortality up to 90 days after extended surgery Major Adverse Kidney Events (MAKE) up to 90 days after extended surgery combined endpoint consisting of mortality, renal replacement therapy, persistent renal dysfunction defined as serum-creatinine \>= 1.5 times as compared to baseline serum-creatinine
Hospital stay up to 90 days after extended surgery (until discharge) Intensive Care Unit stay up to 90 days after extended surgery (until discharge)
Trial Locations
- Locations (82)
University of Alabama
🇺🇸Birmingham, Alabama, United States
CHU d'Angers
🇫🇷Angers, France
Centre Hospitalier Simone Veil de Blois
🇫🇷Blois, France
CHU de Bordeaux
🇫🇷Bordeaux, France
Hopital Privé Sévigné
🇫🇷Cesson-Sévigné, France
Hopital Huriez - CHU de Lille
🇫🇷Lille, France
Centre de Lutte contre le Cancer Francois Baclesse
🇫🇷Caen, 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
Hopital Robert Schuman-Groupe UNEOS
🇫🇷Vantoux, France
CHG Tarbes
🇫🇷Tarbes, France
Clinique Pasteur Toulouse
🇫🇷Toulouse, France
University Hospital Muenster
🇩🇪Muenster, Germany
Kliniken Maria Hilf
🇩🇪Mönchengladbach, Germany
Herz Jesu Krankenhaus Münster Hiltrup
🇩🇪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
Tripoli Central Hospital
🇱🇾Tripoli, Libyan Arab Jamahiriya
Ospedale Sant'Eugenio di Roma
🇮🇹Rome, Italy
National Heart Center Tripoli
🇱🇾Tripoli, Libyan Arab Jamahiriya
Mater Dei Hospital
🇲🇹Birkirkara, Malta
Al-Shifa Medical Complex
🇵🇸Gaza City, Palestinian Territory, occupied
Bakulev Scientific Center for Cardiovascular Surgery
🇷🇺Moscow, Russian Federation
Alia Governmental Hospital
🇵🇸Hebron, Palestinian Territory, occupied
Kemerovo Cardiology Centre
🇷🇺Kemerovo, Russian Federation
Polenov Neurosurgical Institute
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario Araba
🇪🇸Alava, Spain
Hospital Universitario Funcacion Alcorcón
🇪🇸Alcorcón, Spain
Urology Fundación Puigvert
🇪🇸Barcelona, Spain
Donostia University Hospital
🇪🇸Donostia, Spain
Hospital CliÃnico Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
San Pedro Hospital
🇪🇸Logroño, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
Infanta Leonor University Hospital
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Son Llatzer University Hospital
🇪🇸Palma De Mallorca, Spain
Cukurova University
🇹🇷Adana, Turkey
Akdeniz University Hospital
🇹🇷Akdeniz, Turkey
Ankara City Hospital
🇹🇷Ankara, Turkey
Kahramanmaras Sutcu Imam University
🇹🇷Ankara, Turkey
Balikesir University
🇹🇷Balıkesir, Turkey
Uludag University
🇹🇷Bursa, Turkey
University of Health Sciences
🇹🇷Bursa, Turkey
Haseki Egitim Arastirma
🇹🇷Istanbul, Turkey
Health Sciences University Medical School
🇹🇷Derince, Turkey
Gazi University Hospital
🇹🇷Gazi, Turkey
Acibadem MAA Ãœnv. Atakent Acibadem
🇹🇷Istanbul, Turkey
Acibadem MAA Ünv. Altunizade Ä'Acibadem
🇹🇷Istanbul, Turkey
Istanbul University - Cerrahpasa
🇹🇷Istanbul, Turkey
Istanbul University
🇹🇷Istanbul, Turkey
Koc University Hospital
🇹🇷Istanbul, Turkey
Prof. Dr. Cemil Tascioglu City Hospital
🇹🇷Istanbul, Turkey
Yeditepe
🇹🇷Istanbul, Turkey
Dokuz Eylül Üniversitesi
🇹🇷İzmir, Turkey
Health Sciences University Kartal
🇹🇷Kartal, Turkey
Manisa, Medical Faculty
🇹🇷Manisa, Turkey
Izmir Democracy University School of Medicine
🇹🇷İzmir, Turkey
Inönü University Hospital
🇹🇷Malatya, Turkey
Mayis University
🇹🇷Samsun, Turkey
Mersin University
🇹🇷Mersin, Turkey
Karadeniz Technical University
🇹🇷Trabzon, Turkey
University Faculty of Medicine
🇹🇷Trakya, Turkey
Suleyman Demirel University School of Medicine
🇹🇷Merkez, Turkey
Düzce University
🇹🇷Düzce, Turkey
Mansoura University Hospitals
🇪🇬Mansoura, Egypt
University Clinic
🇲🇰Skopje, North Macedonia
Tanta University Faculty of Medicine
🇪🇬Tanta, Egypt
Alexandria University
🇪🇬Alexandria, Egypt
Almana General Hospital
🇸🇦Khobar, Saudi Arabia
Splosna bolnisnica Murska Sobota
🇸🇮Murska Sobota, Slovenia
University Medical Centre Maribor
🇸🇮Ljubljana, Slovenia
Gustave Roussy
🇫🇷Villejuif, France
Ibn Sina Hospital
🇹🇷Ankara, Turkey