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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Kidney Injury (AKI)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with extended surgical exposures<br>Patients with extended surgical exposures requiring postoperative observation. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, injury, surgery