GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery

Study Overview
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Brief Summary
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This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients

Detailed Description
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This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.

Official Title
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Multi-center, Prospective, Randomized Outcome Study Comparing Continuous Cardiac Index Trending Via a Radial Arterial Line Versus Standard Care in General Surgical Patients

Conditions
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Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications

Intervention / Treatment
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* Device: measurement of cardiac output and pulse pressure variation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major abdominal surgery duration of surgery > 2 hours Exclusion Criteria: age < 18 years scheduled postoperative icu treatment

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation, measurement of cardiac output and pulse pressure variation, hemodynamic optimization according to cardiac index and pulse pressure variation | Device: measurement of cardiac output and pulse pressure variation<br>* hemodynamic optimization according to cardiac index and pulse pressure variation<br>|
| No Intervention: Control group<br>hemodynamic management according to institutional clinical standards | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF) | Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Stay | length of stay in the postoperative care unit, length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 10 days |