Intraoperative Perfusion Index and Mortality

September 6, 2025 updated by: Frederik Lau, Copenhagen University Hospital, Hvidovre

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

425000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital - Hvidovre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 30 days from time of surgery
30 days from time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Adverse Outcome
Time Frame: 30 days from time of surgery

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)
30 days from time of surgery
Postoperative ICU Admission
Time Frame: 30 days from date of surgery
Any ICU admission occurring after index surgery and within 30 days.
30 days from date of surgery
Reoperation
Time Frame: 30 days from date of surgery
Any return to the operating room within 30 days of index surgery.
30 days from date of surgery
Prolonged Length of Stay (LOS)
Time Frame: Through hospital discharge (max. 6 months from surgery date)
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.
Through hospital discharge (max. 6 months from surgery date)
Acute Kidney Injury
Time Frame: 30 days from date of surgery
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.
30 days from date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Investigators

  • Study Director: Nicolai B Foss, Prof, Copenhagen University Hospital, Hvidovre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 25, 2025

First Submitted That Met QC Criteria

September 6, 2025

First Posted (Estimated)

September 10, 2025

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 6, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • F-24084045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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