Personalized Hemodynamic Management in High-risk Major Abdominal Surgery

NCT ID: NCT05648279

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-08
• Study Completion Date: 2025-12-31

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.

Detailed Description

not provided

Conditions

Cardiac Output; Surgery; Postoperative Complications; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Personalized hemodynamic management

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernd Saugel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Medical University of Graz

Graz, , Austria

Site Status: RECRUITING

University Hospital Plzen

Pilsen, , Czechia

Site Status: NOT_YET_RECRUITING

Hvidovre Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

University Medical Center Copenhagen Bispebjerg and Frederiksberg

Copenhagen, , Denmark

Site Status: RECRUITING

University Hospital RWTH Aachen

Aachen, , Germany

Site Status: NOT_YET_RECRUITING

University Hospital Düsseldorf

Düsseldorf, , Germany

Site Status: RECRUITING

University Medical Center Hamburg

Hamburg, , Germany

Site Status: RECRUITING

University Medical Center Schleswig Holstein, Lübeck

Lübeck, , Germany

Site Status: RECRUITING

University Hospital Marburg

Marburg, , Germany

Site Status: RECRUITING

LMU Munich

Munich, , Germany

Site Status: RECRUITING

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status: RECRUITING

Countries

Austria; Czechia; Denmark; Germany; Spain

Central Contacts

Bernd Saugel, M.D.

Role: CONTACT

b.saugel@uke.de

004940741052415

Moritz Flick, M.D.

Role: CONTACT

m.flick@uke.de

004940741052415

Facility Contacts

Michael Eichlseder

Role: primary

Jan Benes

Role: primary

Rune Sort

Role: primary

Eske Aasvang

Role: primary

Christian S Meyhoff

Role: primary

Jan Larmann

Role: primary

Sebastian Roth

Role: primary

Bernd Saugel

Role: primary

Moritz Steinhaus

Role: primary

Benjamin Vojnar

Role: primary

Agnes Meidert

Role: primary

Marc Vives

Role: primary

Other Identifiers

2022-100955-BO-ff

Identifier Type: -

Identifier Source: org_study_id