NCT07164339

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
425,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

August 25, 2025

Last Update Submit

September 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    30 days from time of surgery

Secondary Outcomes (5)

  • Composite Adverse Outcome

    30 days from time of surgery

  • Postoperative ICU Admission

    30 days from date of surgery

  • Reoperation

    30 days from date of surgery

  • Prolonged Length of Stay (LOS)

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

  • Acute Kidney Injury

    30 days from date of surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital - Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 38242802BACKGROUND
  • 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.

    PMID: 34226038BACKGROUND

Study Officials

  • Nicolai B Foss, Prof

    Copenhagen University Hospital, Hvidovre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 10, 2025

Study Start

December 18, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data cannot be made available due to ethical and regulatory restrictions.

Locations