Vital Values at Circadian Markers in Postoperative Patients

June 9, 2023 updated by: Jesper Mølgaard, Rigshospitalet, Denmark

Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications

To describe changes in various diurnal patterns in vital values after surgery. These will be analyzed based on whether the patients have complications or no complications.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

589

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
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients are drawn from two studies:

Clinical trials registry: NCT03491137 and NCT04473001

Description

Inclusion Criteria:

  • Admitted for surgery
  • Expected time of surgery was more than 2 hours.
  • Expected post-operative length of stay was more than 2 days.

Exclusion Criteria:

  • Allergy to study materials
  • Patients with a pacemaker
  • Patients that were expected to be unable to cooperate with study procedures (for instance a Mini-Mental State Exam(MMSE < 25)

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

Cohorts and Interventions

Group / Cohort
Patients without postoperative complications
Patients with postoperative complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: From start of continuous monitoring until 12 hours after monitoring stopped.

Any complication meeting the ICH-GCP serious adverse event(SAE) criteria:

An SAE (...) is defined as any untoward medical occurrence that(...)

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalization or causes prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Requires intervention to prevent permanent impairment or damage

(May have caused a congenital anomaly/birth defect - Not relevant)
From start of continuous monitoring until 12 hours after monitoring stopped.

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

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)

February 20, 2018

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

February 12, 2021

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WARD-X-CIRC

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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