Personalized Hemodynamic Management in High-risk Major Abdominal Surgery

Surgery Clinical Trial

— PELICAN  

Official title:

Personalized Hemodynamic Management Targeting Preoperative Baseline Cardiac Index in High-risk Patients Having Major Abdominal Surgery: the International Multicenter Randomized PELICAN Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648279
• Other study ID #: 2022-100955-BO-ff
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Bernd Saugel, M.D.
• Phone: 004940741052415
• Email: b.saugel[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

not provided

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1128
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cardiac Output
• Postoperative Complications
• Surgery

Intervention

Other:
• 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). 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.

Locations

Country	Name	City	State
Denmark	University Medical Center Copenhagen Bispebjerg and Frederiksberg	Copenhagen
Germany	University Medical Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Composite outcome of major postoperative complications	Collapsed incidence of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, severe infectious complications, and death within 3 days after surgery.	Postoperative Day 3
Secondary	Postoperative acute kidney injury	Incidence of acute kidney injury within 3 days after surgery	Postoperative Day 3
Secondary	Postoperative acute kidney injury	Incidence of acute kidney injury within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative acute myocardial injury	Incidence of acute myocardial injury within 3 days after surgery	Postoperative Day 3
Secondary	Postoperative acute myocardial injury	Incidence of acute myocardial injury within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative severe infectious complications	Incidence of a composite outcome of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection, unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 3 days after surgery.	Postoperative Day 3
Secondary	Postoperative severe infectious complications	Incidence of a composite outcome of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection, unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery.	Postoperative Day 7
Secondary	Postoperative non-fatal cardiac arrest	Incidence of postoperative non-fatal cardiac arrest within 3 days after surgery	Postoperative Day 3
Secondary	Postoperative non-fatal cardiac arrest	Incidence of postoperative non-fatal cardiac arrest within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative death	Incidence of postoperative death within 3 days after surgery	Postoperative Day 3
Secondary	Postoperative death	Incidence of postoperative death within 7 days after surgery	Postoperative Day 7
Secondary	Composite outcome of long-term postoperative complications	Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days after surgery	Postoperative Day 30
Secondary	Composite outcome of long-term postoperative complications	Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 90 days after surgery	Postoperative Day 90
Secondary	Postoperative need for renal replacement therapy	Incidence of need for renal replacement therapy within 30 days after surgery	Postoperative Day 30
Secondary	Postoperative need for renal replacement therapy	Incidence of need for renal replacement therapy within 90 days after surgery	Postoperative Day 90
Secondary	Postoperative myocardial infarction	Incidence of myocardial infarction within 30 days after surgery	Postoperative Day 30
Secondary	Postoperative myocardial infarction	Incidence of myocardial infarction within 90 days after surgery	Postoperative Day 90
Secondary	Postoperative non-fatal cardiac arrest	Incidence of non-fatal cardiac arrest within 30 days after surgery	Postoperative Day 30
Secondary	Postoperative non-fatal cardiac arrest	Incidence of non-fatal cardiac arrest within 90 days after surgery	Postoperative Day 90
Secondary	Postoperative death	Incidence of death within 30 days after surgery	Postoperative Day 30
Secondary	Postoperative death	Incidence of death within 90 days after surgery	Postoperative Day 90
Secondary	Postoperative fever	Incidence of fever within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative respiratory infection	Incidence of respiratory infection within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative neurological infection	Incidence of neurological infection within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative urinary system infection	Incidence of urinary system infection within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative colitis or infection with Clostridium difficile	Incidence of colitis or infection with Clostridium difficile within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative endometritis	Incidence of endometritis within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative deep incisional surgical site infection	Incidence of deep incisional surgical site infection within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative organ or space surgical site infection	Incidence of organ or space surgical site infection within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative unknown infection with pathogenic organisms in tissue or fluid	Incidence of unknown infection with pathogenic organisms in tissue or fluid within 7 days after surgery	Postoperative Day 7
Secondary	Postoperative sepsis	Incidence of sepsis within 7 days after surgery	Postoperative Day 7
Secondary	Transfer from intensive care unit to normal ward	Time-to-event endpoint with the event "transfer from intensive care unit to normal ward" within 90 days after surgery	Postoperative Day 90
Secondary	Hospital discharge	Time-to-event endpoint with the event "hospital discharge" within 90 days after surgery	Postoperative Day 90
Secondary	Unplanned hospital re-admission	Incidence of unplanned hospital re-admission within 30 days after surgery	Postoperative Day 30