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Study medication without approval and stop of financial support
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kidney treatment bundle (KDIGO) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kidney treatment bundle (KDIGO) | Procedure | Application of the measures of the kidney treatment bundle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative AKI | AKI according to KDIGO definition | until day 5 after surgery |
| 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) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Wunder, MD | University of Wuerzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Wuerzburg, Dep. of Anesthesiology | Würzburg | 97080 | Germany |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |