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OpenTrials
Completed

NCT Number: NCT05347784

Vital Values at Circadian Markers in Postoperative Patients

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.

Completed

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Key information

Conditions

Postoperative Complications Circadian Dysrhythmia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2022
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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