Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support

Study Overview
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Brief Summary
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Background Intraoperative hypotension is a common problem that significantly contributes to perioperative mortality and morbidity. At the moment the gold standard for perioperative fluid management is the so called goal-directed therapy that features fluid resuscitation followed if necessary catecholamines if needed for perioperative cardiocirculatory support. Worldwide the so called physiological sodium chlorid (0.9% NaCl) solution is the most often used infusate for perioperative fluid management. Despite its widespread use physiological saline has its major disadvantages such as the increased incidence of metabolic acidosis. Nevertheless catecholamines have their significant side effects as well (eg diminished renal perfusion, increased cardiovascular morbidity) and they therefore should be used with caution. In a prior study by group members on patients undergoing renal transplantation receiving either physiological saline or an acetate-buffered infusate showed a 50% decrease in catecholamine necessity in the acetate-buffered infusate group. The investigators therefore would like to evaluate the effects of the perioperative fluid choice on the necessity of catecholamine use. Aim Evaluation of the perioperative fluid choice on the necessity of catecholamines for cardiocirculatory support. Description of the relationship between perioperative fluid choice and minimal blood pressure as well as the time to catecholamine use and their dosage. Methods The investigators plan a prospective randomized-controlled trial of all patients undergoing major abdominal surgery at the Vienna General Hospital and Medical University of Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based treatment scheme.

Official Title
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Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support, a Randomized Controlled Double-blind Trial

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: vasopressor
* Drug: fluid bolus
* Device: oesophagus doppler (CardioQ)
* Drug: Normal Saline
* Device: arterial cannulation
* Device: intravenous peripheral line insertion (17 gauge)
* Drug: Elo-Mel Isoton (balanced acetat-based infusate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients scheduled for open elective major abdominal surgery and expected to last a minimum of 2 hours will be included in the study. (Major abdominal surgery includes all gynecological, urological and general surgical operations requiring laparotomy) Exclusion Criteria: Patients younger than 18 years of age Patients unable to give informed consent Pregnancy or breastfeeding Patients transferred form the intensive care unit to the operating theater Patients with an already established catecholamine therapy Emergency operation Chronic inflammatory diseases (chronic inflammatory rheumatoid diseases, chronic inflammatory renal diseases, chronic inflammatory infectious diseases, chronic inflammatory bowel diseases, chronic liver disease with signs of liver insufficiency) Severe cardiovascular disease (heart disease with an ejection fraction below 30%, instable coronary syndromes, severe valvular disease) Any signs of infection or sepsis Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic pathology, planned oesophageal resection) Renal insufficiency with a glomerular filtration rate below 30ml/min Patients with additional epidural anesthesia are excluded from the study if epidural anesthesia is planned to be used for analgesia intraoperatively

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NaCl 0.9% BBraun (normale saline)<br>154mmol/l sodium, 154mmol/l chloride | Drug: vasopressor<br>* Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor<br>* Other names: phenylephrine, norepinephrine;Drug: fluid bolus<br> <br> Device: oesophagus doppler (CardioQ)<br> <br> Drug: Normal Saline<br> <br> Device: arterial cannulation<br> <br> Device: intravenous peripheral line insertion (17 gauge)<br>* for fluid bolus administration<br>|
| Active Comparator: Elo-Mel Isoton (balanced acetat-based infusate)<br>sodium 140mmol/l, potassium 5.0mmol/l, calcium 2.5mmol/l, magnesium 1.5mmol/l, chlorid 108mmol/l, acetate 45mmol/l | Drug: vasopressor<br>* Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor<br>* Other names: phenylephrine, norepinephrine;Drug: fluid bolus<br> <br> Device: oesophagus doppler (CardioQ)<br> <br> Device: arterial cannulation<br> <br> Device: intravenous peripheral line insertion (17 gauge)<br>* for fluid bolus administration<br>Drug: Elo-Mel Isoton (balanced acetat-based infusate)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catecholamine use to maintain target mean arterial pressure |  | hours of anesthesia (max 10 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in dose of catecholamines to maintain cardiovascular stability |  | hours of anesthesia (max 10 hours) | 
| difference in volume to maintain cardiovascular stability |  | hours of anesthesia (max 10 hours) | 
| unplanned ICU transfers |  | hours of anesthesia (max 10 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid Management