Not provided
Not provided
Not provided
Not provided
Patient Safety
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaCl 0.9% BBraun (normale saline) | Active Comparator | 154mmol/l sodium, 154mmol/l chloride |
|
| Elo-Mel Isoton (balanced acetat-based infusate) | Active Comparator | sodium 140mmol/l, potassium 5.0mmol/l, calcium 2.5mmol/l, magnesium 1.5mmol/l, chlorid 108mmol/l, acetate 45mmol/l |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vasopressor | Drug | Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor |
|
| Measure | Description | Time Frame |
|---|---|---|
| catecholamine use to maintain target mean arterial pressure | hours of anesthesia (max 10 hours) |
| 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) |
Not provided
Inclusion Criteria:
(Major abdominal surgery includes all gynecological, urological and general surgical operations requiring laparotomy)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Klaus Markstaller, MD | Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Anesthesiology, Intensive Care and Pain Management, Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29406176 | Derived | Pfortmueller CA, Funk GC, Reiterer C, Schrott A, Zotti O, Kabon B, Fleischmann E, Lindner G. Normal saline versus a balanced crystalloid for goal-directed perioperative fluid therapy in major abdominal surgery: a double-blind randomised controlled study. Br J Anaesth. 2018 Feb;120(2):274-283. doi: 10.1016/j.bja.2017.11.088. Epub 2017 Dec 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| fluid bolus | Drug |
|
| oesophagus doppler (CardioQ) | Device |
|
| Normal Saline | Drug |
|
| arterial cannulation | Device |
|
| intravenous peripheral line insertion (17 gauge) | Device | for fluid bolus administration |
|
| Elo-Mel Isoton (balanced acetat-based infusate) | Drug |
|
| unplanned ICU transfers | hours of anesthesia (max 10 hours) |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014662 | Vasoconstrictor Agents |
| D010656 | Phenylephrine |
| D009638 | Norepinephrine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided