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NCT Number: NCT05090254

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment algorithms targeting cardiac output

Other

Treatment algorithms targeting maximization or personalization of cardiac output

Primary outcomes

  1. Perioperative changes in oxygen delivery

    Time frame: 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

  2. Perioperative changes in oxygen consumption

    Time frame: 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

Secondary outcomes

  1. Perioperative changes of microcirculation

    Time frame: 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

  2. Perioperative changes in cardiac output

    Time frame: 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

Other outcomes

  1. Incidence of postoperative myocardial injury

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

    assessed via blood samples

  2. Incidence of acute kidney injury

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

    assessed via blood samples

  3. Perioperative changes in urethral perfusion index

    Time frame: 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 urethral photoplethysmography

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Acronym: CUSTOM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2021
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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