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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

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.

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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.

Conditions

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Major Non-cardiac Surgery

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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P group

Fluid Management according to measurements with PiCCO®

PiCCO® Monitoring

Intervention Type DEVICE

Fluid and vasopressor management according to PiCCO measruements

C group

Conventional fluid management

PiCCO® Monitoring

Intervention Type DEVICE

Fluid and vasopressor management according to PiCCO measruements

Interventions

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PiCCO® Monitoring

Fluid and vasopressor management according to PiCCO measruements

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No