Personalized Hemodynamic Management in High-risk Major Abdominal Surgery

Last updated: May 9, 2025
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Anesthesia

Treatment

Personalized hemodynamic management

Clinical Study ID

NCT05648279
2022-100955-BO-ff
  • Ages > 18
  • All Genders

Study 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 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 major abdominal surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Consenting patients ≥45 years scheduled for elective major abdominal surgery 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 theAmerican College of Cardiology/American Heart Association

  • renal impairment (serum creatinine ≥1.3 mg dL-1 or estimated glomerular filtrationrate <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 Cushingthreshold])

  • 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 anesthesia 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

Exclusion Criteria:

  • emergency 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 of preoperative baseline cardiac index assessment using bioreactance

  • impossibility to perform cardiac index monitoring using the Starling FluidManagement System (Baxter, Deerfield, IL, USA)

  • current participation in another clinical trial or treatment with a similarbiological mechanism or primary outcome measure

Study Design

Total Participants: 1128
Treatment Group(s): 1
Primary Treatment: Personalized hemodynamic management
Phase:
Study Start date:
October 08, 2023
Estimated Completion Date:
December 31, 2025

Study Description

not provided

Connect with a study center

  • Hvidovre Hospital

    Copenhagen,
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • University Medical Center Copenhagen Bispebjerg and Frederiksberg

    Copenhagen,
    Denmark

    Active - Recruiting

  • University Hospital Düsseldorf

    Düsseldorf,
    Germany

    Active - Recruiting

  • University Medical Center Hamburg

    Hamburg,
    Germany

    Active - Recruiting

  • University Medical Center Schleswig Holstein, Lübeck

    Lübeck,
    Germany

    Active - Recruiting

  • University Hospital Marburg

    Marburg,
    Germany

    Active - Recruiting

  • LMU Munich

    Munich,
    Germany

    Active - Recruiting

  • Clínica Universidad de Navarra

    Pamplona,
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.