Personalized Hemodynamic Management in High-risk Major Abdominal Surgery

NCT05648279 | Completed DMC

• 1 other identifier: 2022-100955-BO-ff
• Study Type: interventional
• Target: 1,128
• Locations: 5 countries
• Sites: 12

Brief Summary

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.

Conditions

Anesthesia; Surgery; Postoperative Complications; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (34)

• Composite outcome of major postoperative complications

  Postoperative Day 3

• Postoperative acute kidney injury

  Postoperative Day 3

• Postoperative acute kidney injury

  Postoperative Day 7

• Postoperative acute myocardial injury

  Postoperative Day 3

• Postoperative acute myocardial injury

  Postoperative Day 7

Study Arms (2)

Routine hemodynamic management (control)

NO INTERVENTION

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.

Personalized hemodynamic management (intervention)

EXPERIMENTAL

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

Interventions

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.

Personalized hemodynamic management (intervention)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (12)

Medical University of Graz

Graz, Austria

Location

University Hospital Plzen

Pilsen, Czechia

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

University Medical Center Copenhagen Bispebjerg and Frederiksberg

Copenhagen, Denmark

Location

University Hospital RWTH Aachen

Aachen, Germany

Location

University Hospital Düsseldorf

Düsseldorf, Germany

Location

University Medical Center Hamburg

Hamburg, Germany

Location

University Medical Center Schleswig Holstein, Lübeck

Lübeck, Germany

Location

University Hospital Marburg

Marburg, Germany

Location

LMU Munich

Munich, Germany

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

Related Publications (1)

• Flick M, Aasvang EK, Eichlseder M, Klimovic A, Meidert AS, Meyhoff CS, Roth S, Steinhaus M, Sort R, Vives M, Vojnar B, Ziemann S, Krause L, Vettorazzi E, Zapf A, Kouz K, Saugel B. Personalized hemodynamic management targeting preoperative baseline cardiac index in high-risk patients having major abdominal surgery: rationale and design of the international multicenter randomized PELICAN trial. Trials. 2026 Mar 28. doi: 10.1186/s13063-026-09657-9. Online ahead of print.

  PMID: 41904483 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernd Saugel, M.D.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In patients in the routine management group, the treating anesthesiologists will be blinded to data of preoperative baseline cardiac output measurements to avoid performance bias. Participanting patients, outcome assessors, and data analysts are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: October 8, 2023
• Primary Completion: October 25, 2025
• Study Completion: January 15, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date 12 months after article publication End date: 5 years after article publication
• Access Criteria: Written request to Principal Investigator

Locations

DK (3); AU (1); CZ (1); ES (1); DE (6)