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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05347784
Other study ID # WARD-X-CIRC
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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.
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