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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165369
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital Muenster

Study Description
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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.


Condition or disease
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., ICU, IMC, PACU) 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 Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury
Actual Study Start Date : June 9, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022
Groups and Cohorts
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Group/Cohort
Patients with extended surgical exposures
Patients with extended surgical exposures requiring postoperative observation.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Acute Kidney Injury [ Time Frame: 72 hours after extended surgery ]
    Occurrence of acute kidney injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria


Secondary Outcome Measures :
  1. Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3) [ Time Frame: 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

  2. Number of patients with renal replacement therapy [ Time Frame: up to 90 days after extended surgery ]
  3. Mortality [ Time Frame: up to 90 days after extended surgery ]
  4. Hospital stay [ Time Frame: up to 90 days after extended surgery (until discharge) ]
  5. Intensive Care Unit stay [ Time Frame: up to 90 days after extended surgery (until discharge) ]
  6. MAKE (major adverse kidney events) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing extended surgical procedure and the need for postoperative observation
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165369


Contacts
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Contact: Alexander Zarbock, MD, PhD +49-251-47252 zarbock@uni-muenster.de
Contact: Melanie Meersch, MD, PhD +49-251-47255 meersch@uni-muenster.de

Locations
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Germany
University Hospital Muenster Recruiting
Muenster, Germany, D-48149
Contact: Raphael Weiss, MD       epis-aki@ukmuenster.de   
Herz Jesu Krankenhaus Münster Hiltrup Recruiting
Münster, Germany, 48165
St. Josef-Stift Sendenhorst Recruiting
Sendenhorst, Germany, 48324
Malta
Mater Dei Hospital Recruiting
Birkirkara, Malta, MSD-2090
Slovenia
University Medical Centre Maribor Recruiting
Ljubljana, Slovenia, SI-2000
Sponsors and Collaborators
University Hospital Muenster
Baxter Healthcare Corporation
Investigators
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Study Chair: Alexander Zarbock, MD, PhD University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine
More Information
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04165369    
Other Study ID Numbers: 01-AnIt-19
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
Acute kidney injury
injury
surgery
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases