NCT05347784

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 20, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.9 years

First QC Date

April 20, 2022

Last Update Submit

June 9, 2023

Conditions

Postoperative ComplicationsCircadian Dysrhythmia

Keywords

Postoperative physiologyVital signs

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    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.

Study Arms (2)

Patients without postoperative complications

Patients with postoperative complications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are drawn from two studies: Clinical trials registry: NCT03491137 and NCT04473001

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

February 20, 2018

Primary Completion

January 15, 2021

Study Completion

February 12, 2021

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

DK(1)