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

Not Applicable

Completed

• Conditions: Caridac Output-guided Goal-directed Hemodynamic Therapy; Major Non-cardiac Surgery; Postoperative Acute Myocardial Injury; Postoperative Acute Kidney Injury; Oxygen Delivery; Oxygen Consumption; Microcirculatory Perfusion
• Interventions: Other: Treatment algorithms targeting cardiac output

• Registration Number: NCT05090254
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-29
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac output personalization group	Treatment algorithms targeting cardiac output	Patients will be treated according to a goal-directed therapy protocol aiming at a personalized cardiac output goal determined with preoperative cardiac output assessment. Detailed protocol adapted from Nicklas, J.Y., et al., Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth, 2020. 125(2): p. 122-132.
Cardiac output maximization group	Treatment algorithms targeting cardiac output	Patients will be treated according to a goal-directed therapy protocol aiming at a cardiac output maximization. Detailed protocol adapted from Edwards, M.R., et al., Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery. BMJ Open, 2019. 9(1): p. e023455.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany