The Effect of Perioperative Cardiac Output-guided GDT on Oxygen Delivery, Consumption, and Microcirculatory Perfusion

Oxygen Consumption Clinical Trial

— CUSTOM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090254
• Other study ID #: 2021-10141-BO-ff
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Major Non-cardiac Surgery
• Microcirculatory Perfusion
• Oxygen Consumption
• Oxygen Delivery
• Postoperative Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Treatment algorithms targeting cardiac output
Treatment algorithms targeting maximization or personalization of cardiac output

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of postoperative myocardial injury	assessed via blood samples	baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery
Other	Incidence of acute kidney injury	assessed via blood samples	baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery
Other	Perioperative changes in urethral perfusion index	assessed via urethral photoplethysmography	after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery
Primary	Perioperative changes in oxygen delivery	assessed via blood gas analysis	after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery
Primary	Perioperative changes in oxygen consumption	assessed via indirect calorimetry	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	Perioperative changes of microcirculation	assessed via Incident Darkfield technology	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	Perioperative changes in cardiac output	assessed via pulse wave analysis	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