Caridac Output-guided Goal-directed Hemodynamic Therapy, Major Non-cardiac Surgery, Microcirculatory Perfusion, Oxygen Consumption, Oxygen Delivery, Postoperative Acute Kidney Injury, Postoperative Acute Myocardial Injury
Conditions
Keywords
non-cardiac surgery, oxygen consumption, oxygen delivery, microcirculatory perfusion, goal-directed hemodynamic therapy
Brief summary
Perioperative cardiac output-guided goal-directed therapy (GDT) triggers fluid, vasopressor, and inotrope administration assuming that optimizing cardiac output (i.e., global blood flow) ensures adequate oxygen delivery and microcirculatory perfusion - that are usually not directly monitored during goal-directed therapy. There is increasing evidence that perioperative cardiac output-guided goal-directed therapy may reduce postoperative complications compared to routine hemodynamic management in high-risk patients having major surgery. The effect of cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as microcirculatory perfusion, however, is unknown. The investigators aim to investigate the effect of using different cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as sublingual microcirculatory perfusion compared to routine perioperative hemodynamic management in patients having major abdominal surgery with general anesthesia.
Detailed description
Perioperative cardiac output-guided goal-directed therapy (GDT) triggers fluid, vasopressor, and inotrope administration assuming that optimizing cardiac output (i.e., global blood flow) ensures adequate oxygen delivery and microcirculatory perfusion - that are usually not directly monitored during goal-directed therapy. There is increasing evidence that perioperative cardiac output-guided goal-directed therapy may reduce postoperative complications compared to routine hemodynamic management in high-risk patients having major surgery. The effect of cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as microcirculatory perfusion, however, is unknown. With technological advancements a distinct monitoring of oxygen delivery and consumption as well as microcirculatory perfusion in the perioperative period has become possible. Using new technologies, a detailed understanding of the effect of cardiac output-guided goal-directed therapy on perioperative oxygen delivery and consumption as well as microcirculatory perfusion is of vital importance to further develop and improve perioperative hemodynamic treatment strategies. In this pilot randomized-controlled trial, the investigators therefore aim to investigate the effect of using different cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as sublingual microcirculatory perfusion compared to routine perioperative hemodynamic management in patients having major abdominal surgery with general anesthesia.
Interventions
OTHERTreatment algorithms targeting cardiac output
Treatment algorithms targeting maximization or personalization of cardiac output
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) having elective major abdominal surgery with general anesthesia * Expected duration of surgery at least 120 minutes * Planned postoperative monitoring in intensive care unit
Exclusion criteria
* Emergency surgery * Age \<18 years * Body weight \<50 kg * Pregnancy * Atrial fibrillation * Planned patient positioning in other position than supine position * Surgery within the last 30 days * Inaccessibility of the head during surgery * Peripheral artery disease stage ≥IIb * Chronic vasculitis * Supraglottic airway management * Enterostomy repair surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative changes in oxygen delivery | after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery | assessed via blood gas analysis |
| Perioperative changes in oxygen consumption | baseline awake, after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery | assessed via indirect calorimetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative changes of microcirculation | baseline awake, after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery | assessed via Incident Darkfield technology |
| Perioperative changes in cardiac output | baseline awake, after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery | assessed via pulse wave analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury | baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery | assessed via blood samples |
| Perioperative changes in urethral perfusion index | after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery | assessed via urethral photoplethysmography |
| Incidence of postoperative myocardial injury | baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery | assessed via blood samples |
Countries
Germany
Outcome results
None listed