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Acute Kidney Injury (AKI)Epis-AKINCT04165369

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

An observational study of Acute Kidney Injury (AKI), run by University Hospital Muenster at 82 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury (AKI)
How many people
10,568 participants
Where
82 sitesin 14 countries
Study dates
9 Jun 2020to 31 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

82 sites in 14 countries.

82 sites in 14 countries

Turkey (Türkiye)29 sites

  • Cukurova University

    Adana

  • Akdeniz University Hospital

    Akdeniz

  • Ankara City Hospital

    Ankara

  • Ibn Sina Hospital

    Ankara

  • Kahramanmaras Sutcu Imam University

    Ankara

  • Balikesir University

    Balıkesir

  • Uludag University

    Bursa

  • University of Health Sciences

    Bursa

  • Suleyman Demirel University School of Medicine

    Center

  • Health Sciences University Medical School

    Derince

  • Düzce University

    Düzce

  • Gazi University Hospital

    Gazi

  • Acibadem MAA Ünv. Altunizade Ä'Acibadem

    Istanbul

  • Acibadem MAA Ünv. Atakent Acibadem

    Istanbul

  • Haseki Egitim Arastirma

    Istanbul

  • Istanbul University - Cerrahpasa

    Istanbul

  • Istanbul University

    Istanbul

  • Koc University Hospital

    Istanbul

  • Prof. Dr. Cemil Tascioglu City Hospital

    Istanbul

  • Yeditepe

    Istanbul

  • Dokuz Eylül Üniversitesi

    Izmir

  • Izmir Democracy University School of Medicine

    Izmir

  • Health Sciences University Kartal

    Kartal

  • Inönü University Hospital

    Malatya

  • Manisa, Medical Faculty

    Manisa

  • Mersin University

    Mersin

  • Mayis University

    Samsun

  • Karadeniz Technical University

    Trabzon

  • University Faculty of Medicine

    Trakya

Other trials in Turkey (Türkiye)

France17 sites

  • CHU d'Angers

    Angers

  • Centre Hospitalier Simone Veil de Blois

    Blois

  • CHU de Bordeaux

    Bordeaux

  • Centre de Lutte contre le Cancer Francois Baclesse

    Caen

  • Hopital Privé Sévigné

    Cesson-Sévigné

  • Hopital Huriez - CHU de Lille

    Lille

  • Clinique Chénieux

    Limoges

  • Hopital Edouard Herriot

    Lyon

  • Centre Hospitalier des Pays de Morlaix

    Morlaix

  • CHU de Nices

    Nice

  • Hopital Bichat

    Paris

  • Hopital Maison Blance

    Reims

  • Clinique Sainte-Anne

    Strasbourg

  • CHG Tarbes

    Tarbes

  • Clinique Pasteur Toulouse

    Toulouse

  • Hopital Robert Schuman-Groupe UNEOS

    Vantoux

  • Gustave Roussy

    Villejuif

Other trials in France

Spain11 sites

  • Hospital Universitario Araba

    Alava

  • Hospital Universitario Funcacion Alcorcón

    Alcorcón

  • Urology Fundación Puigvert

    Barcelona

  • Donostia University Hospital

    Donostia / San Sebastian

  • Hospital Cliínico Universitario Virgen de las Nieves

    Granada

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria

  • San Pedro Hospital

    Logroño

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Infanta Leonor University Hospital

    Madrid

  • Son Llatzer University Hospital

    Palma de Mallorca

Other trials in Spain

Germany5 sites

  • Kliniken Maria Hilf

    Mönchengladbach

  • Herz Jesu Krankenhaus Münster Hiltrup

    Münster, 48165

  • University Hospital Muenster

    Münster, D-48149

  • St. Josef-Stift Sendenhorst

    Sendenhorst, 48324

  • Universitätsklinikum Tübingen

    Tübingen

Other trials in Germany

Italy4 sites

  • Ospedale di Montebelluna

    Montebelluna

  • University of Palermo

    Palermo

  • Cardioanestesia - Azienda Ospedaliera San Carlo di Potenza

    Potenza

  • Ospedale Sant'Eugenio di Roma

    Rome

Other trials in Italy

Egypt3 sites

  • Mansoura University Hospitals

    Al Mansurah

  • Alexandria University

    Alexandria

  • Tanta University Faculty of Medicine

    Tanta

Other trials in Egypt

Russia3 sites

  • Kemerovo Cardiology Centre

    Kemerovo

  • Bakulev Scientific Center for Cardiovascular Surgery

    Moscow

  • Polenov Neurosurgical Institute

    Saint Petersburg

Other trials in Russia

Libya2 sites

  • National Heart Center Tripoli

    Tripoli

  • Tripoli Central Hospital

    Tripoli

Palestinian Territories2 sites

  • Al-Shifa Medical Complex

    Gaza

  • Alia Governmental Hospital

    Hebron

Other trials in Palestinian Territories

Slovenia2 sites

  • University Medical Centre Maribor

    Ljubljana, SI-2000

  • Splosna bolnisnica Murska Sobota

    Murska Sobota

Other trials in Slovenia

United States1 site

  • University of Alabama

    Birmingham, Alabama, 35294

Other trials in United States

Malta1 site

  • Mater Dei Hospital

    Birkirkara, MSD-2090

Other trials in Malta

North Macedonia1 site

  • University Clinic

    Skopje

Other trials in North Macedonia

Saudi Arabia1 site

  • Almana General Hospital

    Khobar

Other trials in Saudi Arabia

About this study

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.

Read the 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.

Keywords
Acute kidney injury, injury, surgery
Medical subject headings
Acute Kidney Injury, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04165369
Study groupRoleWhat they receive
Patients with extended surgical exposuresPatients with extended surgical exposures requiring postoperative observation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Acute Kidney Injury

    Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

    Measured: 72 hours after extended surgery

Secondary outcomes (6)

  1. 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

    Measured: 72 hours after extended surgery

  2. Number of patients with renal replacement therapy

    Measured: up to 90 days after extended surgery

  3. Mortality

    Measured: up to 90 days after extended surgery

  4. Hospital stay

    Measured: up to 90 days after extended surgery (until discharge)

  5. Intensive Care Unit stay

    Measured: up to 90 days after extended surgery (until discharge)

  6. 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

    Measured: up to 90 days after extended surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start9 Jun 2020
  3. Primary completion28 Feb 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04165369
Sponsor's protocol ID
01-AnIt-19
Acronym
Epis-AKI
Status last verified
Jul 2022
First submitted
30 Oct 2019
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38285051

  • Zarbock 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.

    PubMed 37505258

  • 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.

    PubMed 35588372

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury (AKI), run by University Hospital Muenster at 82 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Turkey (Türkiye), France, Spain, Germany, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Acute Kidney Injury (time frame: 72 hours after extended surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04165369, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.

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