Prevention of Postoperative Acute Kidney Injury

Study Overview
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Brief Summary
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Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.

Detailed Description
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All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.

Official Title
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Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Procedure: kidney treatment bundle (KDIGO)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age > 65 years chronic kidney disease diabetes mellitus, chronic heart, lung or liver disease hemodynamic instability (intra and/or post-operative) trauma, burn injury, major surgery, usage of x-ray contrast and sepsis. Exclusion criteria: Age < 18 years pregnancy kidney graft recipient chronic renal disease with or without renal replacement therapy and cardiac surgery.

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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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kidney treatment bundle (KDIGO)<br>Consequent postoperative application of a kidney treatment bundle: Protocol based hemodynamic optimization and monitoring, regular screening of creatinine in serum and of urine output, no use of potential nephrotoxic medication and normoglycemia. | Procedure: kidney treatment bundle (KDIGO)<br>* Application of the measures of the kidney treatment bundle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative AKI | AKI according to KDIGO definition | until day 5 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit mortality |  | 28 days and 90 days after surgery | 
| hospital mortality |  | up to 100 days after surgery | 
| usage of renal replacement therapy (hours) |  | up to 30 days after surgery | 
| length of invasive respirator therapy (hours) |  | up to 30 days after surgery | 
| creatinine in serum |  | 12 hours, day 2, 3, 5 and 10 after surgery | 
| urine output (total ml) |  | after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery | 
| length of hospital stay |  | up to 100 days after surgery | 
| length of ICU stay |  | up to 100 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute kidney injury, hemodynamic stabilisation, nephrotoxic medication