Vital Values at Circadian Markers in Postoperative Patients

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347784
• Other study ID #: WARD-X-CIRC
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: February 12, 2021

Study information

• Verified date: June 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: February 12, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Circadian Dysrhythmia
• Postoperative Complications

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.