Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury (Epis-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.

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury (AKI)

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.

• Study Type: Observational
• Enrollment (Actual): 10568

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria University
  • Mansoura, Egypt
    • Mansoura University Hospitals
  • Tanta, Egypt
    • Tanta University Faculty of medicine
• France
  • Angers, France
    • CHU d'Angers
  • Blois, France
    • Centre Hospitalier Simone Veil de Blois
  • Bordeaux, France
    • CHU de Bordeaux
  • Caen, France
    • Centre de Lutte Contre le Cancer François Baclesse
  • Cesson-Sévigné, France
    • Hôpital Privé Sévigné
  • Lille, France
    • Hôpital Huriez - CHU de Lille
  • Limoges, France
    • Clinique Chenieux
  • Lyon, France
    • Hôpital Edouard Herriot
  • Morlaix, France
    • Centre hospitalier des pays de Morlaix
  • Nice, France
    • CHU de Nices
  • Paris, France
    • Hôpital Bichat
  • Reims, France
    • Hopital Maison Blance
  • Strasbourg, France
    • Clinique Sainte-Anne
  • Tarbes, France
    • CHG Tarbes
  • Toulouse, France
    • Clinique Pasteur Toulouse
  • Vantoux, France
    • Hôpital Robert Schuman-Groupe UNEOS
  • Villejuif, France
    • Gustave Roussy
• Germany
  • Muenster, Germany, D-48149
    • University Hospital Muenster
  • Mönchengladbach, Germany
    • Kliniken Maria Hilf
  • Münster, Germany, 48165
    • Herz Jesu Krankenhaus Münster Hiltrup
  • Sendenhorst, Germany, 48324
    • St. Josef-Stift Sendenhorst
  • Tübingen, Germany
    • Universitätsklinikum Tübingen
• Italy
  • Montebelluna, Italy
    • Ospedale di Montebelluna
  • Palermo, Italy
    • University of Palermo
  • Potenza, Italy
    • Cardioanestesia - Azienda Ospedaliera San Carlo di Potenza
  • Rome, Italy
    • Ospedale Sant'Eugenio di Roma
• Libyan Arab Jamahiriya
  • Tripoli, Libyan Arab Jamahiriya
    • National Heart Center Tripoli
  • Tripoli, Libyan Arab Jamahiriya
    • Tripoli Central Hospital
• Malta
  • Birkirkara, Malta, MSD-2090
    • Mater Dei Hospital
• North Macedonia
  • Skopje, North Macedonia
    • University Clinic
• Palestinian Territory, occupied
  • Gaza City, Palestinian Territory, occupied
    • Al-Shifa Medical Complex
  • Hebron, Palestinian Territory, occupied
    • Alia Governmental Hospital
• Russian Federation
  • Kemerovo, Russian Federation
    • Kemerovo Cardiology Centre
  • Moscow, Russian Federation
    • Bakulev Scientific Center for Cardiovascular Surgery
  • Saint Petersburg, Russian Federation
    • Polenov Neurosurgical Institute
• Saudi Arabia
  • Khobar, Saudi Arabia
    • Almana General Hospital
• Slovenia
  • Ljubljana, Slovenia, SI-2000
    • University Medical Centre Maribor
  • Murska Sobota, Slovenia
    • Splosna bolnisnica Murska Sobota
• Spain
  • Alava, Spain
    • Hospital Universitario Araba
  • Alcorcón, Spain
    • Hospital Universitario Funcacion Alcorcón
  • Barcelona, Spain
    • Urology Fundación Puigvert
  • Donostia, Spain
    • Donostia University Hospital
  • Granada, Spain
    • Hospital Cliínico Universitario Virgen de las Nieves
  • Las Palmas De Gran Canaria, Spain
    • Hospital Universitario de Gran Canaria Doctor Negrín
  • Logroño, Spain
    • San Pedro Hospital
  • Madrid, Spain
    • Hospital Ramon y Cajal
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Infanta Leonor University Hospital
  • Palma De Mallorca, Spain
    • Son LLatzer University Hospital
• Turkey
  • Adana, Turkey
    • Çukurova university
  • Akdeniz, Turkey
    • Akdeniz University Hospital
  • Ankara, Turkey
    • Ankara City Hospital
  • Ankara, Turkey
    • Ibn Sina Hospital
  • Ankara, Turkey
    • Kahramanmaras Sutcu Imam University
  • Balıkesir, Turkey
    • Balikesir University
  • Bursa, Turkey
    • Uludag University
  • Bursa, Turkey
    • University of Health Sciences
  • Derince, Turkey
    • Health Sciences University Medical School
  • Düzce, Turkey
    • Duzce University
  • Gazi, Turkey
    • Gazi University Hospital
  • Istanbul, Turkey
    • Istanbul University
  • Istanbul, Turkey
    • İstanbul University - Cerrahpaşa
  • Istanbul, Turkey
    • Koc University Hospital
  • Istanbul, Turkey
    • Acibadem MAA Ünv. Altunizade Ä'Acibadem
  • Istanbul, Turkey
    • Acibadem MAA Ünv. Atakent Acibadem
  • Istanbul, Turkey
    • Haseki Egitim Arastirma
  • Istanbul, Turkey
    • Prof. Dr. Cemil Tascioglu City Hospital
  • Istanbul, Turkey
    • Yeditepe
  • Kartal, Turkey
    • Health Sciences University Kartal
  • Malatya, Turkey
    • Inönü University Hospital
  • Manisa, Turkey
    • Manisa, Medical Faculty
  • Merkez, Turkey
    • Suleyman Demirel University School of Medicine
  • Mersin, Turkey
    • Mersin University
  • Samsun, Turkey
    • Mayis University
  • Trabzon, Turkey
    • Karadeniz Technical University
  • Trakya, Turkey
    • University Faculty of Medicine
  • İzmir, Turkey
    • Dokuz Eylul Universitesi
  • İzmir, Turkey
    • Izmir Democracy University School of Medicine
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing extended surgical procedure and the need for postoperative observation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with extended surgical exposures; Patients with extended surgical exposures requiring postoperative observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)	Definition and classification of acute injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guidelines on acute kidney injury	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)
Major Adverse Kidney Events (MAKE)	combined endpoint consisting of mortality, renal replacement therapy, persistent renal dysfunction defined as serum-creatinine >= 1.5 times as compared to baseline serum-creatinine	up to 90 days after extended surgery

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Baxter Healthcare Corporation
• Investigators: Study Chair: Alexander Zarbock, MD, PhD, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 9, 2020
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: surgery; injury; Acute kidney injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 01-AnIt-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No