Endothelial DysfunctionEDOPNCT03014765
Endothelial Dysfunction in Perioperative Period
A study testing EDOP in people with Endothelial Dysfunction and Postoperative Complications, run by University Medical Centre Ljubljana.
Trial summary
Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Endothelial Dysfunction, Postoperative Complications
- What is being tested?
- EDOP
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2017to 8 Dec 2017
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled hip arthroplasty under spinal anesthesia
Who cannot join
- Acute coronary syndrome or cerebrovascular syndrome in the last 6 months
- Acute venous thrombosis in the last 6 months
- Episode of rheumatoid arthritis in the last 3 months or permanent therapy with prednisolone >4mg/day
- Acute illness or hospitalization in the last month
- Chronic kidney failure on dialysis
- Hepatic failure
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- Active malignant disease
- Immunosuppression after organ transplantation
- Pregnancy
- No informed consent after oral and written information
About this study
Official title: Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period
Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after cuff deflation. From above mentioned values the increase in the diameter of the artery during reactive hyperemia will be calculated.
Simultaneously with the ultrasound investigations, the blood for determination of the endothelial dysfunction markers will be collected.
The participants will be contacted again 3 months after the surgery and asked about the complications which may be associated with the surgery.
Read the detailed description
Cardiovascular complications, especially coronary heart disease, are one of the main causes of perioperative complications. Indicators of pre-clinical atherosclerosis, such as: endothelial dysfunction, increased arterial intima/media thickness (especially in the carotid arteries), carotid calcification and coronary calcification, suggest the presence of atherosclerotic process without the symptomatic presentation. Endothelial dysfunction is one of the earliest measurable changes that predict the development of atherosclerotic disease.
Surgery is a significant stress for the organism: it increases the release of free oxygen radicals and through oxidative stress it increases systemic inflammatory response and causes thromboembolic complications.
In the study 50 patients of both sexes 40-80 years of age scheduled for hip arthroplasty will be included. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. Measurement of the brachial artery flow-mediated dilatation capability (FMD): the brachial artery diameter will be measured 5 cm proximal to the antecubital fossa at rest, during cuff inflation and 50 seconds after cuff deflation. The cuff will be inflated for 4 min. From above mentioned values the increase in the diameter of the artery during reactive hyperemia will be calculated.
Simultaneously with the ultrasound investigations, the blood for determination of the inflammatory and endothelial dysfunction markers (CRP, IL-6, IL-8, IL-10, IL-18, TNFa, VW Factor, Selectin P, selectin E) will be collected.
The participants will be contacted again 3 months after the surgery and asked about the complications which may be associated with the surgery.
- Being tested
- EDOP
- Keywords
- endothelial dysfunction, perioperative stress, cardiovascular complications, inflammatory markers
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDOPOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction
Measured: 12 months
Secondary outcomes (2)
levels of blood circulating markers of increased perioperative stress and systemic inflammatory response
levels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa
Measured: 12 months
decrease in endothelial function
reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start3 Jan 2017
- Primary completion16 Jun 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University
- Responsible party
- Principal investigator, Peter Poredos, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014765
- Sponsor's protocol ID
- MZ 0120-446/2015-2
- Acronym
- EDOP
- Status last verified
- May 2018
- First submitted
- 4 Jan 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period
- ClinicalTrials.gov ID
- NCT03014765
- Acronym / sponsor ID
- EDOP / MZ 0120-446/2015-2
- Keywords
- endothelial dysfunction, perioperative stress, cardiovascular complications, inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Loyola University
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- 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.
Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after cuff deflation. From above mentioned values the increase in the diameter of the artery during reactive hyperemia will be calculated.
Simultaneously with the ultrasound investigations, the blood for determination of the endothelial dysfunction markers will be collected.
The participants will be contacted again 3 months after the surgery and asked about the complications which may be associated with the surgery.
Detailed description
Cardiovascular complications, especially coronary heart disease, are one of the main causes of perioperative complications. Indicators of pre-clinical atherosclerosis, such as: endothelial dysfunction, increased arterial intima/media thickness (especially in the carotid arteries), carotid calcification and coronary calcification, suggest the presence of atherosclerotic process without the symptomatic presentation. Endothelial dysfunction is one of the earliest measurable changes that predict the development of atherosclerotic disease.
Surgery is a significant stress for the organism: it increases the release of free oxygen radicals and through oxidative stress it increases systemic inflammatory response and causes thromboembolic complications.
In the study 50 patients of both sexes 40-80 years of age scheduled for hip arthroplasty will be included. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. Measurement of the brachial artery flow-mediated dilatation capability (FMD): the brachial artery diameter will be measured 5 cm proximal to the antecubital fossa at rest, during cuff inflation and 50 seconds after cuff deflation. The cuff will be inflated for 4 min. From above mentioned values the increase in the diameter of the artery during reactive hyperemia will be calculated.
Simultaneously with the ultrasound investigations, the blood for determination of the inflammatory and endothelial dysfunction markers (CRP, IL-6, IL-8, IL-10, IL-18, TNFa, VW Factor, Selectin P, selectin E) will be collected.
The participants will be contacted again 3 months after the surgery and asked about the complications which may be associated with the surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled hip arthroplasty under spinal anesthesia
Key exclusion criteria (10 listed)
- Acute coronary syndrome or cerebrovascular syndrome in the last 6 months
- Acute venous thrombosis in the last 6 months
- Episode of rheumatoid arthritis in the last 3 months or permanent therapy with prednisolone >4mg/day
- Acute illness or hospitalization in the last month
- Chronic kidney failure on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDOPno intervention | Other | – |
Primary outcome
rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction
Time frame: 12 months
2 secondary outcomes
levels of blood circulating markers of increased perioperative stress and systemic inflammatory response
Time frame: 12 months
decrease in endothelial function
Time frame: 12 months
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 8 May 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing EDOP in people with Endothelial Dysfunction and Postoperative Complications, run by University Medical Centre Ljubljana.
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 1 inclusion and 10 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 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction (time frame: 12 months). 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 8 May 2018.