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NCT Number: NCT05648279

Personalized Hemodynamic Management in High-risk Major Abdominal Surgery

Postoperative mortality within 30 days after surgery is around 2% in patients having major noncardiac surgery in Europe and the USA. In fact, if the first 30 days after surgery were considered a disease, it would be the third leading cause of death globally. Postoperative deaths are a consequence of postoperative organ injury and complications - including acute myocardial injury, acute kidney injury, and severe infectious complications. To avoid postoperative deaths, it is thus crucial to reduce postoperative organ injury and complications. To reduce postoperative organ injury and complications, modifiable risk factors need to be addressed. These modifiable risk factors for postoperative organ injury include low blood flow states and intraoperative hypotension. Optimizing blood flow (i.e., cardiac index) during surgery may thus be effective in reducing postoperative organ injury and complications. However, the optimal hemodynamic treatment strategy for high-risk surgical patients remains unclear. Cardiac index varies substantially between individuals. However, current intraoperative hemodynamic treatment strategies mainly aim to maximize cardiac index instead of using personalized cardiac index targets for each individual patient. A single-center pilot trial suggests that using individualized cardiac index targets during surgery may reduce postoperative organ injury and complications compared to routine hemodynamic management. However, large robust trials investigating the effect of personalized hemodynamic management targeting preoperative baseline cardiac index on postoperative complications are missing.

The investigators, therefore, propose a multicenter randomized trial to test the hypothesis that personalized intraoperative hemodynamic management targeting preoperative baseline cardiac index reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, severe infectious complications, and death within 7 days after surgery compared to routine hemodynamic management in high-risk patients having elective major abdominal surgery.

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Key information

Conditions

Cardiac Output Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgery

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Graz, Austria

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About this study

not provided

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Consenting patients ≥45 years scheduled for elective major abdominal surgery (involving visceral organs) under general anesthesia that is expected to last ≥90 minutes AND presence of ≥1 of the following high-risk criteria:

  • exercise tolerance <4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/American Heart Association
  • renal impairment (serum creatinine ≥1.3 mg dL-1 or estimated glomerular filtration rate <90 mL min-1 (1.73 m2)-1 within the last 6 months
  • coronary artery disease
  • chronic heart failure (New York Heart Association Functional Classification ≥II)
  • valvular heart disease (moderate or severe)
  • history of stroke
  • peripheral arterial occlusive disease (any stage)
  • chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)
  • diabetes mellitus requiring oral hypoglycemic agent or insulin
  • immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids [above Cushing threshold])
  • liver cirrhosis (any Child-Pugh class)
  • body mass index ≥30 kg m-2
  • history of smoking within two years of surgery
  • age ≥65 years
  • expected surgery duration ≥180 minutes
  • B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic peptide (NT-proBNP) >200 ng/L within the last 6 months

Exclusion criteria

  • emergency surgery
  • ambulatory surgery
  • planned surgery: nephrectomy, liver or kidney transplantation surgery
  • status post transplantation of kidney, liver, heart, or lung
  • sepsis (according to current Sepsis-3 definition)
  • American Society of Anesthesiologists physical status classification V or VI
  • pregnancy
  • impossibility to perform cardiac index monitoring using the Starling Fluid Management System (Baxter, Deerfield, IL, USA)
  • current participation in another clinical trial or treatment with a similar biological mechanism or primary outcome measure

Treatment and study plan

Personalized hemodynamic management

Other

Personalized hemodynamic management: Intraoperative cardiac index will be maintained at least at the preoperative baseline cardiac index. Preoperative baseline cardiac index will be determined one day before surgery with the patient being awake and resting in the supine position using the Starling Fluid Management System (Baxter, Deerfield, IL, USA) Preoperative baseline cardiac index will be determined with the patient being awake and resting in supine position using the Starling Fluid Management System (Baxter, Deerfield, IL, USA) (usually at least one day before surgery). We will define the individual preoperative baseline cardiac index as the average value over a 5 min period at rest (minimum cardiac index threshold: 2.2 L min-1 m-2). Intraoperative cardiac index will be measured using the Baxter Starling Fluid Management System.

Primary outcomes

  1. Composite outcome of major postoperative complications

    Time frame: Postoperative Day 7

    Collapsed composite ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, severe infectious complications, and death within 7 days after surgery.

Secondary outcomes

  1. Composite outcome of major postoperative complications

    Time frame: Postoperative Day 3

    Collapsed incidence of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, severe infectious complications, and death within 3 days after surgery.

  2. Postoperative acute kidney injury

    Time frame: Postoperative Day 3

    Incidence of acute kidney injury within 3 days after surgery

  3. Postoperative acute kidney injury

    Time frame: Postoperative Day 7

    Incidence of acute kidney injury within 7 days after surgery

  4. Postoperative acute myocardial injury

    Time frame: Postoperative Day 3

    Incidence of acute myocardial injury within 3 days after surgery

  5. Postoperative acute myocardial injury

    Time frame: Postoperative Day 7

    Incidence of acute myocardial injury within 7 days after surgery

  6. Postoperative severe infectious complications

    Time frame: Postoperative Day 3

    Incidence of a composite outcome of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection (including anastomotic leak), unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 3 days after surgery.

  7. Postoperative severe infectious complications

    Time frame: Postoperative Day 7

    Incidence of a composite outcome of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection (including anastomotic leak), unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery.

  8. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 3

    Incidence of postoperative non-fatal cardiac arrest within 3 days after surgery

  9. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 7

    Incidence of postoperative non-fatal cardiac arrest within 7 days after surgery

  10. Postoperative death

    Time frame: Postoperative Day 3

    Incidence of postoperative death within 3 days after surgery

  11. Postoperative death

    Time frame: Postoperative Day 7

    Incidence of postoperative death within 7 days after surgery

  12. Composite outcome of long-term postoperative complications

    Time frame: Postoperative Day 30

    Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days after surgery

  13. Composite outcome of long-term postoperative complications

    Time frame: Postoperative Day 90

    Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 90 days after surgery

  14. Postoperative need for renal replacement therapy

    Time frame: Postoperative Day 30

    Incidence of need for renal replacement therapy within 30 days after surgery

  15. Postoperative need for renal replacement therapy

    Time frame: Postoperative Day 90

    Incidence of need for renal replacement therapy within 90 days after surgery

  16. Postoperative myocardial infarction

    Time frame: Postoperative Day 30

    Incidence of myocardial infarction within 30 days after surgery

  17. Postoperative myocardial infarction

    Time frame: Postoperative Day 90

    Incidence of myocardial infarction within 90 days after surgery

  18. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 30

    Incidence of non-fatal cardiac arrest within 30 days after surgery

  19. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 90

    Incidence of non-fatal cardiac arrest within 90 days after surgery

  20. Postoperative death

    Time frame: Postoperative Day 30

    Incidence of death within 30 days after surgery

  21. Postoperative death

    Time frame: Postoperative Day 90

    Incidence of death within 90 days after surgery

  22. Postoperative fever

    Time frame: Postoperative Day 7

    Incidence of fever within 7 days after surgery

  23. Postoperative respiratory infection

    Time frame: Postoperative Day 7

    Incidence of respiratory infection within 7 days after surgery

  24. Postoperative neurological infection

    Time frame: Postoperative Day 7

    Incidence of neurological infection within 7 days after surgery

  25. Postoperative urinary system infection

    Time frame: Postoperative Day 7

    Incidence of urinary system infection within 7 days after surgery

  26. Postoperative colitis or infection with Clostridium difficile

    Time frame: Postoperative Day 7

    Incidence of colitis or infection with Clostridium difficile within 7 days after surgery

  27. Postoperative endometritis

    Time frame: Postoperative Day 7

    Incidence of endometritis within 7 days after surgery

  28. Postoperative deep incisional surgical site infection

    Time frame: Postoperative Day 7

    Incidence of deep incisional surgical site infection within 7 days after surgery

  29. Postoperative organ or space surgical site infection

    Time frame: Postoperative Day 7

    Incidence of organ or space surgical site infection (including anastomotic leak) within 7 days after surgery

  30. Postoperative unknown infection with pathogenic organisms in tissue or fluid

    Time frame: Postoperative Day 7

    Incidence of unknown infection with pathogenic organisms in tissue or fluid within 7 days after surgery

  31. Postoperative sepsis

    Time frame: Postoperative Day 7

    Incidence of sepsis within 7 days after surgery

  32. Transfer from intensive care unit to normal ward

    Time frame: Postoperative Day 90

    Time-to-event endpoint with the event "transfer from intensive care unit to normal ward" within 90 days after surgery

  33. Hospital discharge

    Time frame: Postoperative Day 90

    Time-to-event endpoint with the event "hospital discharge" within 90 days after surgery

  34. Unplanned hospital re-admission

    Time frame: Postoperative Day 30

    Incidence of unplanned hospital re-admission within 30 days after surgery

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Personalized Hemodynamic Management Targeting Preoperative Baseline Cardiac Index in High-risk Patients Having Major Abdominal Surgery: the International Multicenter Randomized PELICAN Trial

Acronym: PELICAN

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 13, 2022
Registry last updated
Feb 5, 2026

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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