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

NCT ID: NCT05090254

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cardiac output maximization group

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.

Group Type: ACTIVE_COMPARATOR

Treatment algorithms targeting cardiac output

Intervention Type: OTHER

Treatment algorithms targeting maximization or personalization of cardiac output

Cardiac output personalization group

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.

Group Type: ACTIVE_COMPARATOR

Treatment algorithms targeting cardiac output

Intervention Type: OTHER

Treatment algorithms targeting maximization or personalization of cardiac output

Routine management group

Patients will be treated according to routine hemodynamic management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Treatment algorithms targeting cardiac output

Treatment algorithms targeting maximization or personalization of cardiac output

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernd Saugel, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

The University Medical Center Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

2021-10141-BO-ff

Identifier Type: -

Identifier Source: org_study_id