Clinical trial NCT05090254: The Effect of Perioperative Cardiac Output-guided GDT on Oxygen Delivery, Consumption, and Microcirculatory Perfusion
Official title: The Effect of Perioperative Cardiac Output-guided Goal-directed Hemodynamic Therapy (GDT) on Perioperative Oxygen Delivery, Consumption, and Microcirculatory Perfusion in Comparison to Routine Hemodynamic Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caridac Output-guided Goal-directed Hemodynamic Therapy
Oxygen Delivery
Oxygen Consumption
Microcirculatory Perfusion
Major Non-cardiac Surgery
Postoperative Acute Kidney Injury
Postoperative Acute Myocardial Injury
Keywords: non-cardiac surgery
oxygen consumption
oxygen delivery
microcirculatory perfusion
goal-directed hemodynamic therapy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative changes in oxygen delivery
timeFrame: after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery
measure: Perioperative changes in oxygen consumption
timeFrame: 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
Secondary outcomes:
measure: Perioperative changes of microcirculation
timeFrame: 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
measure: Perioperative changes in cardiac output
timeFrame: 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
Other outcomes:
measure: Incidence of postoperative myocardial injury
timeFrame: baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery
measure: Incidence of acute kidney injury
timeFrame: baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery
measure: Perioperative changes in urethral perfusion index
timeFrame: after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: The University Medical Center Hamburg-Eppendorf
name: Bernd Saugel, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: