Personalized Hemodynamic Management in High-risk Major Abdominal Surgery (PELICAN)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Surgery; Anesthesia; Cardiac Output
• Intervention / Treatment: Other: Personalized hemodynamic management

Detailed Description

not provided

• Study Type: Interventional
• Enrollment (Actual): 1128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University of Graz
• Czechia
  • Pilsen, Czechia
    • University Hospital Plzen
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
  • Copenhagen, Denmark
    • Hvidovre Hospital
  • Copenhagen, Denmark
    • University Medical Center Copenhagen Bispebjerg and Frederiksberg
• Germany
  • Aachen, Germany
    • University Hospital RWTH Aachen
  • Düsseldorf, Germany
    • University Hospital Düsseldorf
  • Hamburg, Germany
    • University Medical Center Hamburg
  • Lübeck, Germany
    • University Medical Center Schleswig Holstein, Lübeck
  • Marburg, Germany
    • University Hospital Marburg
  • Munich, Germany
    • LMU Munich
• Spain
  • Pamplona, Spain
    • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine hemodynamic management (control); In patients assigned to routine hemodynamic management, hemodynamic management will performed as per anesthesiologist preference. Cardiac index monitoring will be will measured using the Baxter Starling Fluid Management System (Baxter, Deerfield, IL, USA). The attending anesthesiologist will be blinded to cardiac index measurements. Cardiac index monitoring can be unblinded upon request. Mean arterial blood pressure will be maintained above 65 mmHg.
Experimental: Personalized hemodynamic management (intervention); In patients assigned to personalized hemodynamic management, intraoperative cardiac index will be maintained at least at the preoperative baseline cardiac index using a predefined treatment algorithm. 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). Mean arterial blood pressure will be maintained above 65 mmHg. The study intervention will start at the beginning of surgery and will end at the end of surgery.	Other: Personalized hemodynamic management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome of major postoperative complications	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.	Postoperative Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome of major postoperative complications	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.	Postoperative Day 3
Postoperative acute kidney injury	Incidence of acute kidney injury within 3 days after surgery	Postoperative Day 3
Postoperative acute kidney injury	Incidence of acute kidney injury within 7 days after surgery	Postoperative Day 7
Postoperative acute myocardial injury	Incidence of acute myocardial injury within 3 days after surgery	Postoperative Day 3
Postoperative acute myocardial injury	Incidence of acute myocardial injury within 7 days after surgery	Postoperative Day 7
Postoperative non-fatal cardiac arrest	Incidence of postoperative non-fatal cardiac arrest within 3 days after surgery	Postoperative Day 3
Postoperative non-fatal cardiac arrest	Incidence of postoperative non-fatal cardiac arrest within 7 days after surgery	Postoperative Day 7
Postoperative death	Incidence of postoperative death within 3 days after surgery	Postoperative Day 3
Postoperative death	Incidence of postoperative death within 7 days after surgery	Postoperative Day 7
Composite outcome of long-term postoperative complications	Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days after surgery	Postoperative Day 30
Composite outcome of long-term postoperative complications	Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 90 days after surgery	Postoperative Day 90
Postoperative need for renal replacement therapy	Incidence of need for renal replacement therapy within 30 days after surgery	Postoperative Day 30
Postoperative need for renal replacement therapy	Incidence of need for renal replacement therapy within 90 days after surgery	Postoperative Day 90
Postoperative myocardial infarction	Incidence of myocardial infarction within 30 days after surgery	Postoperative Day 30
Postoperative myocardial infarction	Incidence of myocardial infarction within 90 days after surgery	Postoperative Day 90
Postoperative non-fatal cardiac arrest	Incidence of non-fatal cardiac arrest within 30 days after surgery	Postoperative Day 30
Postoperative non-fatal cardiac arrest	Incidence of non-fatal cardiac arrest within 90 days after surgery	Postoperative Day 90
Postoperative death	Incidence of death within 30 days after surgery	Postoperative Day 30
Postoperative death	Incidence of death within 90 days after surgery	Postoperative Day 90
Postoperative fever	Incidence of fever within 7 days after surgery	Postoperative Day 7
Postoperative respiratory infection	Incidence of respiratory infection within 7 days after surgery	Postoperative Day 7
Postoperative neurological infection	Incidence of neurological infection within 7 days after surgery	Postoperative Day 7
Postoperative urinary system infection	Incidence of urinary system infection within 7 days after surgery	Postoperative Day 7
Postoperative colitis or infection with Clostridium difficile	Incidence of colitis or infection with Clostridium difficile within 7 days after surgery	Postoperative Day 7
Postoperative endometritis	Incidence of endometritis within 7 days after surgery	Postoperative Day 7
Postoperative deep incisional surgical site infection	Incidence of deep incisional surgical site infection within 7 days after surgery	Postoperative Day 7
Postoperative unknown infection with pathogenic organisms in tissue or fluid	Incidence of unknown infection with pathogenic organisms in tissue or fluid within 7 days after surgery	Postoperative Day 7
Postoperative sepsis	Incidence of sepsis within 7 days after surgery	Postoperative Day 7
Transfer from intensive care unit to normal ward	Time-to-event endpoint with the event "transfer from intensive care unit to normal ward" within 90 days after surgery	Postoperative Day 90
Hospital discharge	Time-to-event endpoint with the event "hospital discharge" within 90 days after surgery	Postoperative Day 90
Unplanned hospital re-admission	Incidence of unplanned hospital re-admission within 30 days after surgery	Postoperative Day 30
Postoperative severe infectious complications	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.	Postoperative Day 3
Postoperative severe infectious complications	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.	Postoperative Day 7
Postoperative organ or space surgical site infection	Incidence of organ or space surgical site infection (including anastomotic leak) within 7 days after surgery	Postoperative Day 7

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Bernd Saugel, M.D., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2023
• Primary Completion (Actual): October 25, 2025
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: 2022-100955-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Start date 12 months after article publication End date: 5 years after article publication
• IPD Sharing Access Criteria: Written request to Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No