Cardiac OutputPELICANNCT05648279
Personalized Hemodynamic Management in High-risk Major Abdominal Surgery
A study testing Personalized hemodynamic management in people with Cardiac Output and Surgery, run by Universitätsklinikum Hamburg-Eppendorf at 12 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiac Output, Surgery, Postoperative Complications
- What is being tested?
- Personalized hemodynamic management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,128 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 8 Oct 2023to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany6 sites
University Hospital RWTH Aachen
Aachen
University Hospital Düsseldorf
Düsseldorf
University Medical Center Hamburg
Hamburg
University Medical Center Schleswig Holstein, Lübeck
Lübeck
University Hospital Marburg
Marburg
LMU Munich
Munich
Denmark3 sites
Hvidovre Hospital
Copenhagen
Rigshospitalet
Copenhagen
University Medical Center Copenhagen Bispebjerg and Frederiksberg
Copenhagen
About this study
Official title: Personalized Hemodynamic Management Targeting Preoperative Baseline Cardiac Index in High-risk Patients Having Major Abdominal Surgery: the International Multicenter Randomized PELICAN Trial
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.
Read the detailed description
not provided
- Conditions
- Cardiac Output, Surgery, Postoperative Complications, Anesthesia
- Being tested
- Personalized hemodynamic management
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized hemodynamic managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine hemodynamic management (control) | No intervention | 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. |
| Personalized hemodynamic management (intervention) | Experimental | 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. Receives: Other: Personalized hemodynamic management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 7
Secondary outcomes (34)
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.
Measured: Postoperative Day 3
Postoperative acute kidney injury
Incidence of acute kidney injury within 3 days after surgery
Measured: Postoperative Day 3
Postoperative acute kidney injury
Incidence of acute kidney injury within 7 days after surgery
Measured: Postoperative Day 7
Postoperative acute myocardial injury
Incidence of acute myocardial injury within 3 days after surgery
Measured: Postoperative Day 3
Postoperative acute myocardial injury
Incidence of acute myocardial injury within 7 days after surgery
Measured: Postoperative Day 7
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 (including anastomotic leak), unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 3 days after surgery.
Measured: Postoperative Day 3
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 (including anastomotic leak), unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery.
Measured: Postoperative Day 7
Postoperative non-fatal cardiac arrest
Incidence of postoperative non-fatal cardiac arrest within 3 days after surgery
Measured: Postoperative Day 3
Postoperative non-fatal cardiac arrest
Incidence of postoperative non-fatal cardiac arrest within 7 days after surgery
Measured: Postoperative Day 7
Postoperative death
Incidence of postoperative death within 3 days after surgery
Measured: Postoperative Day 3
Postoperative death
Incidence of postoperative death within 7 days after surgery
Measured: Postoperative Day 7
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
Measured: Postoperative Day 30
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
Measured: Postoperative Day 90
Postoperative need for renal replacement therapy
Incidence of need for renal replacement therapy within 30 days after surgery
Measured: Postoperative Day 30
Postoperative need for renal replacement therapy
Incidence of need for renal replacement therapy within 90 days after surgery
Measured: Postoperative Day 90
Postoperative myocardial infarction
Incidence of myocardial infarction within 30 days after surgery
Measured: Postoperative Day 30
Postoperative myocardial infarction
Incidence of myocardial infarction within 90 days after surgery
Measured: Postoperative Day 90
Postoperative non-fatal cardiac arrest
Incidence of non-fatal cardiac arrest within 30 days after surgery
Measured: Postoperative Day 30
Postoperative non-fatal cardiac arrest
Incidence of non-fatal cardiac arrest within 90 days after surgery
Measured: Postoperative Day 90
Postoperative death
Incidence of death within 30 days after surgery
Measured: Postoperative Day 30
Postoperative death
Incidence of death within 90 days after surgery
Measured: Postoperative Day 90
Postoperative fever
Incidence of fever within 7 days after surgery
Measured: Postoperative Day 7
Postoperative respiratory infection
Incidence of respiratory infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative neurological infection
Incidence of neurological infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative urinary system infection
Incidence of urinary system infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative colitis or infection with Clostridium difficile
Incidence of colitis or infection with Clostridium difficile within 7 days after surgery
Measured: Postoperative Day 7
Postoperative endometritis
Incidence of endometritis within 7 days after surgery
Measured: Postoperative Day 7
Postoperative deep incisional surgical site infection
Incidence of deep incisional surgical site infection within 7 days after surgery
Measured: Postoperative Day 7
Postoperative organ or space surgical site infection
Incidence of organ or space surgical site infection (including anastomotic leak) within 7 days after surgery
Measured: Postoperative Day 7
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
Measured: Postoperative Day 7
Postoperative sepsis
Incidence of sepsis within 7 days after surgery
Measured: Postoperative Day 7
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
Measured: Postoperative Day 90
Hospital discharge
Time-to-event endpoint with the event "hospital discharge" within 90 days after surgery
Measured: Postoperative Day 90
Unplanned hospital re-admission
Incidence of unplanned hospital re-admission within 30 days after surgery
Measured: Postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start8 Oct 2023
- Primary completion25 Oct 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernd Saugel, M.D., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648279
- Sponsor's protocol ID
- 2022-100955-BO-ff
- Acronym
- PELICAN
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Saugel B, Meidert AS, Meyhoff CS, Sort R, Aasvang EK, Bergholz A, Serir A, Schwartze E, Thomsen KK, Zollner C, Berthold S, Borrmann M, Esser J, Laska A, Scheiermann P, Foss NB, Olsen JW, Madsen LM, Welling AH, Gaik C, Roth S, Schroder J, Vives M, Klimovic A, Eichlseder M, Goldmann S, Renne T, Hedrich H, Vettorazzi E, Zapf A, Kouz K, Flick M; PELICAN Trial Group. Individualized Cardiac Index-Guided Hemodynamic Therapy in High-Risk Patients Undergoing Elective Major Abdominal Surgery: The PELICAN Randomized Clinical Trial. JAMA. 2026 Oct 19. doi: 10.1001/jama.2026.18574. Online ahead of print.
PubMed 42896534Flick M, Aasvang EK, Eichlseder M, Klimovic A, Meidert AS, Meyhoff CS, Roth S, Steinhaus M, Sort R, Vives M, Vojnar B, Ziemann S, Krause L, Vettorazzi E, Zapf A, Kouz K, Saugel B. Personalized hemodynamic management targeting preoperative baseline cardiac index in high-risk patients having major abdominal surgery: rationale and design of the international multicenter randomized PELICAN trial. Trials. 2026 Mar 28;27(1):286. doi: 10.1186/s13063-026-09657-9.
PubMed 41904483
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Hemodynamic Management Targeting Preoperative Baseline Cardiac Index in High-risk Patients Having Major Abdominal Surgery: the International Multicenter Randomized PELICAN Trial
- ClinicalTrials.gov ID
- NCT05648279
- Acronym / sponsor ID
- PELICAN / 2022-100955-BO-ff
- Conditions
- Cardiac Output, Surgery, Postoperative Complications, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine hemodynamic management (control) | No intervention | –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. |
| Personalized hemodynamic management (intervention) | Experimental | Other: Personalized hemodynamic managementIn 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized hemodynamic managementPersonalized 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. | Other | Personalized hemodynamic management (intervention) |
Primary outcome
Composite outcome of major postoperative complications
Time frame: Postoperative Day 7
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.
34 secondary outcomes
Composite outcome of major postoperative complications
Time frame: Postoperative Day 3
Postoperative acute kidney injury
Time frame: Postoperative Day 3
Postoperative acute kidney injury
Time frame: Postoperative Day 7
Postoperative acute myocardial injury
Time frame: Postoperative Day 3
Postoperative acute myocardial injury
Time frame: Postoperative Day 7
Postoperative severe infectious complications
Time frame: Postoperative Day 3
Postoperative severe infectious complications
Time frame: Postoperative Day 7
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 3
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 7
Postoperative death
Time frame: Postoperative Day 3
Postoperative death
Time frame: Postoperative Day 7
Composite outcome of long-term postoperative complications
Time frame: Postoperative Day 30
Composite outcome of long-term postoperative complications
Time frame: Postoperative Day 90
Postoperative need for renal replacement therapy
Time frame: Postoperative Day 30
Postoperative need for renal replacement therapy
Time frame: Postoperative Day 90
Postoperative myocardial infarction
Time frame: Postoperative Day 30
Postoperative myocardial infarction
Time frame: Postoperative Day 90
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 30
Postoperative non-fatal cardiac arrest
Time frame: Postoperative Day 90
Postoperative death
Time frame: Postoperative Day 30
Postoperative death
Time frame: Postoperative Day 90
Postoperative fever
Time frame: Postoperative Day 7
Postoperative respiratory infection
Time frame: Postoperative Day 7
Postoperative neurological infection
Time frame: Postoperative Day 7
Postoperative urinary system infection
Time frame: Postoperative Day 7
Postoperative colitis or infection with Clostridium difficile
Time frame: Postoperative Day 7
Postoperative endometritis
Time frame: Postoperative Day 7
Postoperative deep incisional surgical site infection
Time frame: Postoperative Day 7
Postoperative organ or space surgical site infection
Time frame: Postoperative Day 7
Postoperative unknown infection with pathogenic organisms in tissue or fluid
Time frame: Postoperative Day 7
Postoperative sepsis
Time frame: Postoperative Day 7
Transfer from intensive care unit to normal ward
Time frame: Postoperative Day 90
Hospital discharge
Time frame: Postoperative Day 90
Unplanned hospital re-admission
Time frame: Postoperative Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 42896534Saugel B, Meidert AS, Meyhoff CS, Sort R, Aasvang EK, Bergholz A, Serir A, Schwartze E, Thomsen KK, Zollner C, Berthold S, Borrmann M, Esser J, Laska A, Scheiermann P, Foss NB, Olsen JW, Madsen LM, Welling AH, Gaik C, Roth S, Schroder J, Vives M, Klimovic A, Eichlseder M, Goldmann S, Renne T, Hedrich H, Vettorazzi E, Zapf A, Kouz K, Flick M; PELICAN Trial Group. Individualized Cardiac Index-Guided Hemodynamic Therapy in High-Risk Patients Undergoing Elective Major Abdominal Surgery: The PELICAN Randomized Clinical Trial. JAMA. 2026 Oct 19. doi: 10.1001/jama.2026.18574. Online ahead of print.
- Derived from this study: PubMed 41904483Flick M, Aasvang EK, Eichlseder M, Klimovic A, Meidert AS, Meyhoff CS, Roth S, Steinhaus M, Sort R, Vives M, Vojnar B, Ziemann S, Krause L, Vettorazzi E, Zapf A, Kouz K, Saugel B. Personalized hemodynamic management targeting preoperative baseline cardiac index in high-risk patients having major abdominal surgery: rationale and design of the international multicenter randomized PELICAN trial. Trials. 2026 Mar 28;27(1):286. doi: 10.1186/s13063-026-09657-9.
- Individual participant dataSharing planned: Yes
Related trials for Cardiac Output
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Saugel, M.D. principal investigator
Universitätsklinikum Hamburg-Eppendorf
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized hemodynamic management in people with Cardiac Output and Surgery, run by Universitätsklinikum Hamburg-Eppendorf at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Denmark, Austria, Czechia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of major postoperative complications (time frame: Postoperative Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.