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Tailoring blood flow during surgery may cut deadly complications

NCT ID NCT05648279

Disease control Sponsor: Universitätsklinikum Hamburg-Eppendorf Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large international trial tested whether keeping a patient's blood flow (cardiac index) at their own personal baseline during major abdominal surgery reduces serious complications. Over 1,100 high-risk adults aged 45 and older took part. The goal was to see if this personalized approach lowers the chance of kidney injury, heart injury, severe infections, or death within a week after surgery compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
personalized hemodynamic management (tailoring blood flow during surgery to each patient's own baseline)
What this could lead to
If successful, this approach could become a new standard to reduce serious complications like kidney injury, heart injury, and infections after major abdominal surgery.
What could go wrong
This is a completed trial, but results are not yet published. The benefit may be small or not apply to all high-risk patients. The intervention requires extra monitoring equipment and planning.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,128 people

The number who actually took part.

Started

Oct 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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) * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia Cardiac output Postoperative complications Surgery

Contacts and locations

Locations

  • Clínica Universidad de Navarra

    Pamplona, Spain

  • Hvidovre Hospital

    Copenhagen, Denmark

  • LMU Munich

    Munich, Germany

  • Medical University of Graz

    Graz, Austria

  • Rigshospitalet

    Copenhagen, Denmark

  • University Hospital Düsseldorf

    Düsseldorf, Germany

  • University Hospital Marburg

    Marburg, Germany

  • University Hospital Plzen

    Pilsen, Czechia

  • University Hospital RWTH Aachen

    Aachen, Germany

  • University Medical Center Copenhagen Bispebjerg and Frederiksberg

    Copenhagen, Denmark

  • University Medical Center Hamburg

    Hamburg, Germany

  • University Medical Center Schleswig Holstein, Lübeck

    Lübeck, Germany

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