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HemodynamicNCT07164339

Intraoperative Perfusion Index and Mortality

An observational study of Hemodynamic and Perfusion Index, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will use routinely collected perioperative data to examine the relationship between intraoperative perfusion index and postoperative outcomes, including mortality. Read more about this study

Who is it for?
Ages 18 years and older
How many people
425,000 participants
Where
1 siteDenmark
Study dates
18 Dec 2024to Oct 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: We include every adult patient who underwent general anesthesia for non-cardiac surgery of any type in Danish hospitals in The Capital and Zealand Regions from January 2017 - December 2024.

Who may be able to join

  • Patients above 18 years of age who underwent general anesthesia for non-cardiac surgery of any type

Who cannot join

  • No registration of intraoperative perfusion index or no information on vital status 30 days after surgery

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen University Hospital - Hvidovre

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: Association Between Intraoperative Perfusion Index and Mortality

This study will use routinely collected perioperative data to examine the relationship between intraoperative perfusion index and postoperative outcomes, including mortality.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: 30 days from time of surgery

Secondary outcomes (5)

  1. Composite Adverse Outcome

    Proportion of participants who experience ≥1 of the following within 30 days after index surgery:

    1. Postoperative admission to the intensive care unit
    2. Reoperation (within 30 days)
    3. Prolonged length of stay, defined as length of stay falling within the highest (75th-100th) percentile for the patient's surgical category
    4. Acute kidney injury according to Kidney Disease: Improving Global Outcome (KDIGO) criteria (≥1.5-fold increase from baseline within 7 days after surgery or 0.3 mg dl-1 increase within 48 h)

    Measured: 30 days from time of surgery

  2. Postoperative ICU Admission

    Any ICU admission occurring after index surgery and within 30 days.

    Measured: 30 days from date of surgery

  3. Reoperation

    Any return to the operating room within 30 days of index surgery.

    Measured: 30 days from date of surgery

  4. Prolonged Length of Stay (LOS)

    Proportion of participants whose index-hospitalization LOS (days from surgery to discharge) falls in the 75th-100th percentile for their surgical category, determined from the study cohort distribution and assessed at discharge.

    Measured: Through hospital discharge (max. 6 months from surgery date)

  5. Acute Kidney Injury

    AKI defined by KDIGO criteria (≥1.5× baseline serum creatinine within 7 days or ≥0.3 mg/dL increase within 48 h) occurring within 30 days of surgery.

    Measured: 30 days from date of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start18 Dec 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
425,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07164339
Sponsor's protocol ID
F-24084045
Status last verified
Sep 2025
First submitted
25 Aug 2025
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data cannot be made available due to ethical and regulatory restrictions.

Publications

  • Krone S, Bokoch MP, Kothari R, Fong N, Tallarico RT, Sturgess-DaPrato J, Pirracchio R, Zarbock A, Legrand M. Association between peripheral perfusion index and postoperative acute kidney injury in major noncardiac surgery patients receiving continuous vasopressors: a post hoc exploratory analysis of the VEGA-1 trial. Br J Anaesth. 2024 Apr;132(4):685-694. doi: 10.1016/j.bja.2023.11.054. Epub 2024 Jan 19.

    PubMed 38242802

  • Agerskov M, Thusholdt ANW, Holm-Sorensen H, Wiberg S, Meyhoff CS, Hojlund J, Secher NH, Foss NB. Association of the intraoperative peripheral perfusion index with postoperative morbidity and mortality in acute surgical patients: a retrospective observational multicentre cohort study. Br J Anaesth. 2021 Sep;127(3):396-404. doi: 10.1016/j.bja.2021.06.004. Epub 2021 Jul 3.

    PubMed 34226038

Questions about this trial

What is this clinical trial studying?

An observational study of Hemodynamic and Perfusion Index, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

This study is still under way. Results are not available in the source record yet.

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?

All-cause mortality (time frame: 30 days from time of surgery). 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 NCT07164339, 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 10 Sep 2025.

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