Clinical trial NCT04165369: Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury
Official title: Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury (AKI)
Keywords: Acute kidney injury
injury
surgery
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-11-18
Enrollment: 10568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing extended surgical procedure and the need for postoperative observation

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* preexisting acute kidney injury
* acute kidney injury within the last 3 months
* end stage renal disease with dialysis dependency
* kidney transplant

Primary outcomes:
measure: Incidence of Acute Kidney Injury
timeFrame: 72 hours after extended surgery
Secondary outcomes:
measure: Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)
timeFrame: 72 hours after extended surgery
measure: Number of patients with renal replacement therapy
timeFrame: up to 90 days after extended surgery
measure: Mortality
timeFrame: up to 90 days after extended surgery
measure: Hospital stay
timeFrame: up to 90 days after extended surgery (until discharge)
measure: Intensive Care Unit stay
timeFrame: up to 90 days after extended surgery (until discharge)
measure: Major Adverse Kidney Events (MAKE)
timeFrame: up to 90 days after extended surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Alexandria
country: Egypt
facility: Alexandria University
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
city: Tanta
country: Egypt
facility: Tanta University Faculty of Medicine
city: Angers
country: France
facility: CHU d'Angers
city: Blois
country: France
facility: Centre Hospitalier Simone Veil de Blois
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: Centre de Lutte contre le Cancer Francois Baclesse
city: Cesson-Sévigné
country: France
facility: Hopital Privé Sévigné
city: Lille
country: France
facility: Hopital Huriez - CHU de Lille
city: Limoges
country: France
facility: Clinique Chénieux
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Morlaix
country: France
facility: Centre Hospitalier des Pays de Morlaix
city: Nice
country: France
facility: CHU de Nices
city: Paris
country: France
facility: Hopital Bichat
city: Reims
country: France
facility: Hopital Maison Blance
city: Strasbourg
country: France
facility: Clinique Sainte-Anne
city: Tarbes
country: France
facility: CHG Tarbes
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Vantoux
country: France
facility: Hopital Robert Schuman-Groupe UNEOS
city: Villejuif
country: France
facility: Gustave Roussy
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf
city: Münster
country: Germany
facility: Herz Jesu Krankenhaus Münster Hiltrup
city: Sendenhorst
country: Germany
facility: St. Josef-Stift Sendenhorst
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Montebelluna
country: Italy
facility: Ospedale di Montebelluna
city: Palermo
country: Italy
facility: University of Palermo
city: Potenza
country: Italy
facility: Cardioanestesia - Azienda Ospedaliera San Carlo di Potenza
city: Rome
country: Italy
facility: Ospedale Sant'Eugenio di Roma
city: Tripoli
country: Libyan Arab Jamahiriya
facility: National Heart Center Tripoli
city: Tripoli
country: Libyan Arab Jamahiriya
facility: Tripoli Central Hospital
city: Birkirkara
country: Malta
facility: Mater Dei Hospital
city: Skopje
country: North Macedonia
facility: University Clinic
city: Gaza City
country: Palestinian Territory, occupied
facility: Al-Shifa Medical Complex
city: Hebron
country: Palestinian Territory, occupied
facility: Alia Governmental Hospital
city: Kemerovo
country: Russian Federation
facility: Kemerovo Cardiology Centre
city: Moscow
country: Russian Federation
facility: Bakulev Scientific Center for Cardiovascular Surgery
city: Saint Petersburg
country: Russian Federation
facility: Polenov Neurosurgical Institute
city: Khobar
country: Saudi Arabia
facility: Almana General Hospital
city: Ljubljana
country: Slovenia
facility: University Medical Centre Maribor
city: Murska Sobota
country: Slovenia
facility: Splosna bolnisnica Murska Sobota
city: Alava
country: Spain
facility: Hospital Universitario Araba
city: Alcorcón
country: Spain
facility: Hospital Universitario Funcacion Alcorcón
city: Barcelona
country: Spain
facility: Urology Fundación Puigvert
city: Donostia
country: Spain
facility: Donostia University Hospital
city: Granada
country: Spain
facility: Hospital Cliínico Universitario Virgen de las Nieves
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: Logroño
country: Spain
facility: San Pedro Hospital
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Infanta Leonor University Hospital
city: Palma De Mallorca
country: Spain
facility: Son Llatzer University Hospital
city: Adana
country: Turkey
facility: Cukurova University
city: Akdeniz
country: Turkey
facility: Akdeniz University Hospital
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Ankara
country: Turkey
facility: Ibn Sina Hospital
city: Ankara
country: Turkey
facility: Kahramanmaras Sutcu Imam University
city: Balıkesir
country: Turkey
facility: Balikesir University
city: Bursa
country: Turkey
facility: Uludag University
city: Bursa
country: Turkey
facility: University of Health Sciences
city: Derince
country: Turkey
facility: Health Sciences University Medical School
city: Düzce
country: Turkey
facility: Düzce University
city: Gazi
country: Turkey
facility: Gazi University Hospital
city: Istanbul
country: Turkey
facility: Acibadem MAA Ünv. Altunizade Ä'Acibadem
city: Istanbul
country: Turkey
facility: Acibadem MAA Ünv. Atakent Acibadem
city: Istanbul
country: Turkey
facility: Haseki Egitim Arastirma
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa
city: Istanbul
country: Turkey
facility: Istanbul University
city: Istanbul
country: Turkey
facility: Koc University Hospital
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
city: Istanbul
country: Turkey
facility: Yeditepe
city: İzmir
country: Turkey
facility: Dokuz Eylül Üniversitesi
city: İzmir
country: Turkey
facility: Izmir Democracy University School of Medicine
city: Kartal
country: Turkey
facility: Health Sciences University Kartal
city: Malatya
country: Turkey
facility: Inönü University Hospital
city: Manisa
country: Turkey
facility: Manisa, Medical Faculty
city: Merkez
country: Turkey
facility: Suleyman Demirel University School of Medicine
city: Mersin
country: Turkey
facility: Mersin University
city: Samsun
country: Turkey
facility: Mayis University
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
city: Trakya
country: Turkey
facility: University Faculty of Medicine
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine
name: Alexander Zarbock, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.