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This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.
Acute kidney injury (AKI) is a common complication after major surgery. Many studies showed that AKI is associated with different complications: higher mortality, renal replacement therapy and prolonged hospital stay resulting in higher health care costs.
Until now just a few studies are published on prevention or therapy of AKI after major surgery. Most of these investigations are underpowered or show just marginal benefit. There are no studies published investigating the impact of goal-directed hemodynamic management on renal outcome following non-cardiac major surgery, even though hemodynamic stability seems to be of paramount importance for the kidneys.
Aim of this study is to investigate the impact of a goal directed hemodynamic management on renal outcome after major non-cardiac surgery.
Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management and the Control group, where PICCO data will be collected but will not influence hemodynamic management. In both groups the monitoring with transpulmonary thermodilution will be continued in the intensive care unit until 72 hours after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P group | Fluid Management according to measurements with PiCCO® |
| |
| C group | Conventional fluid management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PiCCO® Monitoring | Device | Fluid and vasopressor management according to PiCCO measruements |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum change in serum creatinine within 3 days | Start of anesthesia until third postoperative day (72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation | All points are additionnally registered one year after the operation via telephone-questionnaire of the patient and his general practitioner | 1 year |
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Inclusion Criteria:
Elective major non-cardiac surgery lasting more than 3 hours with a following intensive care unit stay for more than 3 days:
Age ≥ 18 years
ASA classification I to III
Written informed consent
Exclusion Criteria:
Need for dialysis
Contraindications for an arterial line in the femoral artery:
ASA classification IV to V
Pregnant Woman
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Patients udndergoing Major non-cardiac surgery
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Jungwirth, MD | Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München | Munich | Bavaria | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17119923 | Background | Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21. | |
| 26951105 | Derived | Schmid S, Kapfer B, Heim M, Bogdanski R, Anetsberger A, Blobner M, Jungwirth B. Algorithm-guided goal-directed haemodynamic therapy does not improve renal function after major abdominal surgery compared to good standard clinical care: a prospective randomised trial. Crit Care. 2016 Mar 8;20:50. doi: 10.1186/s13054-016-1237-1. |
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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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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |