Goal Directed Hemodynamic Management and Renal Outcome After Major Non-cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?

Conditions
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Major Non-cardiac Surgery

Intervention / Treatment
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* Device: PiCCO® Monitoring


Participation Criteria
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Eligibility Criteria
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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: gastrectomy pancreas surgery small bowel surgery esophageal surgery 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: stents bypasses severe peripheral artery occlusive disease ASA classification IV to V Pregnant Woman

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 |
| --- | --- |
| P group<br>Fluid Management according to measurements with PiCCO® | Device: PiCCO® Monitoring<br>* Fluid and vasopressor management according to PiCCO measruements<br>|
| C group<br>Conventional fluid management | Device: PiCCO® Monitoring<br>* Fluid and vasopressor management according to PiCCO measruements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum change in serum creatinine within 3 days |  | Start of anesthesia until third postoperative day (72 hours) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major non-cardiac surgery,, hemodynamic management,, PiCCO,, acute kidney injury,, renal outcome