Personalized management of blood flow during major abdominal surgery
Personalized Hemodynamic Management Targeting Preoperative Baseline Cardiac Index in High-risk Patients Having Major Abdominal Surgery: the International Multicenter Randomized PELICAN Trial
NA · Universitätsklinikum Hamburg-Eppendorf · NCT05648279
This study tests if personalized blood flow management during major abdominal surgery can help older patients with certain health issues recover better and avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Copenhagen and 8 other locations) |
| Trial ID | NCT05648279 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on optimizing blood flow management in patients undergoing high-risk major abdominal surgery to reduce postoperative complications and mortality. It targets patients aged 45 and older who have specific high-risk criteria, such as renal impairment or coronary artery disease. The intervention involves personalized hemodynamic management during surgery to maintain optimal cardiac output. By addressing modifiable risk factors related to blood flow and intraoperative hypotension, the study aims to improve patient outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 45 and older scheduled for elective major abdominal surgery with at least one high-risk medical condition.
Not a fit: Patients who are younger than 45 or do not have any of the specified high-risk criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative organ injury and complications, leading to lower mortality rates.
How similar studies have performed: Other studies have shown promising results with personalized hemodynamic management approaches in surgical settings, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen and 8 other locations
- Hvidovre Hospital — Copenhagen, Denmark (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- University Medical Center Copenhagen Bispebjerg and Frederiksberg — Copenhagen, Denmark (RECRUITING)
- University Hospital Düsseldorf — Düsseldorf, Germany (RECRUITING)
- University Medical Center Hamburg — Hamburg, Germany (RECRUITING)
- University Medical Center Schleswig Holstein, Lübeck — Lübeck, Germany (RECRUITING)
- University Hospital Marburg — Marburg, Germany (RECRUITING)
- LMU Munich — Munich, Germany (RECRUITING)
- Clínica Universidad de Navarra — Pamplona, Spain (RECRUITING)
Study contacts
- Principal investigator: Bernd Saugel, M.D. — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Bernd Saugel, M.D.
- Email: b.saugel@uke.de
- Phone: 004940741052415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Output, Surgery, Postoperative Complications, Anesthesia