Postoperative ComplicationsNCT05347784
Vital Values at Circadian Markers in Postoperative Patients
An observational study of Postoperative Complications and Circadian Dysrhythmia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Circadian Dysrhythmia
- How many people
- 589 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2018to 12 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are drawn from two studies: Clinical trials registry: NCT03491137 and NCT04473001
Who may be able to join
- Admitted for surgery
- Expected time of surgery was more than 2 hours.
- Expected post-operative length of stay was more than 2 days.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications
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.
- Conditions
- Postoperative Complications, Circadian Dysrhythmia
- Keywords
- Postoperative physiology, Vital signs
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients without postoperative complications | Not described | |
| Patients with postoperative complications | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From start of continuous monitoring until 12 hours after monitoring stopped.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start20 Feb 2018
- Primary completion15 Jan 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Mølgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347784
- Sponsor's protocol ID
- WARD-X-CIRC
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications
- ClinicalTrials.gov ID
- NCT05347784
- Acronym / sponsor ID
- WARD-X-CIRC
- Conditions
- Postoperative Complications, Circadian Dysrhythmia
- Keywords
- Postoperative physiology, Vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without postoperative complications | – | – |
| Patients with postoperative complications | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are drawn from two studies: Clinical trials registry: NCT03491137 and NCT04473001
Key inclusion criteria (3 listed)
- Admitted for surgery
- Expected time of surgery was more than 2 hours.
- Expected post-operative length of stay was more than 2 days.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Circadian Dysrhythmia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: From start of continuous monitoring until 12 hours after monitoring stopped.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.