Personalized Hemodynamic Management in High-risk Major Abdominal Surgery

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage blood flow during major abdominal surgery to help reduce serious complications and improve recovery for high-risk patients. Researchers believe that by personalizing blood flow targets based on each patient's individual needs, they can decrease the chances of problems like kidney injury, heart issues, and infections after surgery. Currently, many patients receive a standard approach, but this trial will compare that method with a personalized strategy to see which one is more effective.

To participate in the trial, patients need to be at least 45 years old and scheduled for elective major abdominal surgery that will last at least 90 minutes. They should also have at least one high-risk factor, such as kidney problems, heart disease, or a history of stroke. Participants can expect close monitoring during surgery and recovery, with their blood flow managed according to their unique needs. This trial is important because it aims to gather more evidence on whether personalized care can lead to better outcomes for patients undergoing significant surgery.

Gender

ALL

Eligibility criteria

• 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 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 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 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 Fluid Management System (Baxter, Deerfield, IL, USA)
• • current participation in another clinical trial or treatment with a similar biological mechanism or primary outcome measure

Trial Officials