Vital Values at Circadian Markers in Postoperative Patients

Completed

• Conditions: Postoperative Complications; Circadian Dysrhythmia

• Registration Number: NCT05347784
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-20
• Primary Completion: 2021-01-15
• Study Completion: 2021-02-12
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 589

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications	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)

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark