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

NCT05090254 | Completed

• 1 other identifier: 2021-10141-BO-ff
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

• 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

Other Outcomes (3)

• Incidence of postoperative myocardial injury

  baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery

• Incidence of acute kidney injury

  baseline awake, within 6 hours after surgery, and on day 1, 2, and 3 after surgery

• 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

Study Arms (3)

Cardiac output maximization group

ACTIVE COMPARATOR

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.

Other: Treatment algorithms targeting cardiac output

Cardiac output personalization group

ACTIVE COMPARATOR

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.

Other: Treatment algorithms targeting cardiac output

Routine management group

NO INTERVENTION

Patients will be treated according to routine hemodynamic management.

Interventions

Treatment algorithms targeting cardiac output OTHER

Treatment algorithms targeting maximization or personalization of cardiac output

Cardiac output maximization group; Cardiac output personalization group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Study Officials

• Bernd Saugel, Prof., MD

  The University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: October 22, 2021
• Study Start: August 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

DE (1)