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

Acute Kidney Injury (AKI) Clinical Trial

— Epis-AKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165369
• Other study ID #: 01-AnIt-19
• Status: Completed
• Start date: June 9, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2022
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10568
• Est. completion date: March 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (AKI)
• Wounds and Injuries

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria
Egypt	Mansoura University Hospitals	Mansoura
Egypt	Tanta University Faculty of Medicine	Tanta
France	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
Germany	Kliniken Maria Hilf	Mönchengladbach
Germany	University Hospital Muenster	Muenster
Germany	Herz Jesu Krankenhaus Münster Hiltrup	Münster
Germany	St. Josef-Stift Sendenhorst	Sendenhorst
Germany	Universitätsklinikum Tübingen	Tübingen
Italy	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
Libyan Arab Jamahiriya	National Heart Center Tripoli	Tripoli
Libyan Arab Jamahiriya	Tripoli Central Hospital	Tripoli
Malta	Mater Dei Hospital	Birkirkara
North Macedonia	University Clinic	Skopje
Palestinian Territory, occupied	Al-Shifa Medical Complex	Gaza City
Palestinian Territory, occupied	Alia Governmental Hospital	Hebron
Russian Federation	Kemerovo Cardiology Centre	Kemerovo
Russian Federation	Bakulev Scientific Center for Cardiovascular Surgery	Moscow
Russian Federation	Polenov Neurosurgical Institute	Saint Petersburg
Saudi Arabia	Almana General Hospital	Khobar
Slovenia	University Medical Centre Maribor	Ljubljana
Slovenia	Splosna bolnisnica Murska Sobota	Murska Sobota
Spain	Hospital Universitario Araba	Alava
Spain	Hospital Universitario Funcacion Alcorcón	Alcorcón
Spain	Urology Fundación Puigvert	Barcelona
Spain	Donostia University Hospital	Donostia
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
Turkey	Cukurova University	Adana
Turkey	Akdeniz University Hospital	Akdeniz
Turkey	Ankara City Hospital	Ankara
Turkey	Ibn Sina Hospital	Ankara
Turkey	Kahramanmaras Sutcu Imam University	Ankara
Turkey	Balikesir University	Balikesir
Turkey	Uludag University	Bursa
Turkey	University of Health Sciences	Bursa
Turkey	Health Sciences University Medical School	Derince
Turkey	Düzce University	Düzce
Turkey	Gazi University Hospital	Gazi
Turkey	Acibadem MAA Ünv. Altunizade Ä'Acibadem	Istanbul
Turkey	Acibadem MAA Ünv. Atakent Acibadem	Istanbul
Turkey	Haseki Egitim Arastirma	Istanbul
Turkey	Istanbul University	Istanbul
Turkey	Istanbul University - Cerrahpasa	Istanbul
Turkey	Koc University Hospital	Istanbul
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul
Turkey	Yeditepe	Istanbul
Turkey	Dokuz Eylül Üniversitesi	Izmir
Turkey	Izmir Democracy University School of Medicine	Izmir
Turkey	Health Sciences University Kartal	Kartal
Turkey	Inönü University Hospital	Malatya
Turkey	Manisa, Medical Faculty	Manisa
Turkey	Suleyman Demirel University School of Medicine	Merkez
Turkey	Mersin University	Mersin
Turkey	Mayis University	Samsun
Turkey	Karadeniz Technical University	Trabzon
Turkey	University Faculty of Medicine	Trakya
United States	University of Alabama	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Baxter Healthcare Corporation

Countries where clinical trial is conducted

United States,  Egypt,  France,  Germany,  Italy,  Libyan Arab Jamahiriya,  Malta,  North Macedonia,  Palestinian Territory, occupied,  Russian Federation,  Saudi Arabia,  Slovenia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of patients with renal replacement therapy		up to 90 days after extended surgery
Secondary	Mortality		up to 90 days after extended surgery
Secondary	Hospital stay		up to 90 days after extended surgery (until discharge)
Secondary	Intensive Care Unit stay		up to 90 days after extended surgery (until discharge)
Secondary	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