Acute Kidney InjuryDEVARNCT04766047
The Effect of Dexmedetomidine on Kidney Function in EVAR
A study testing Dexmedetomidine in people with Acute Kidney Injury and Dexmedetomidine, run by University of Thessaly at 1 site in Greece.
Trial summary
This study will investigate the effect of dexmedetomidine on the incidence of postoperative acute kidney injury in patients undergoing EVAR under general anesthesia Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Dexmedetomidine, Endovascular Aortic Repair
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 30 Aug 2021to 1 Feb 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective EVAR under general anesthesia
- adult patients 18- 85 years old
- American society of anesthesiologists (ASA) physical status I - IV
Who cannot join
- refusal to participate or sign the informed consent form
- GFR < 50ml/mim
- Bradyarrhythmia <50/min
- Hemodynamic instability
- Known allergy to Dexmedetomidine
- Severe hepatic insufficiency
Trial locations and contacts
1 site in 1 country.
Greece1 site
Univeristy of Thessaly
Larissa, Thessaly, 41110
Eleni Arnaoutoglou, MD, PhD, 2413501370, earnaout@gmail.com
Konstantinos Stamoulis, MD, PhD, +306973335073, kosta171970@icloud.com
About this study
Official title: The Effect of Dexmedetomidine on the Incidence of Acute Kidney Injury in EVAR
This study will investigate the effect of dexmedetomidine on the incidence of postoperative acute kidney injury in patients undergoing EVAR under general anesthesia
Read the detailed description
This study will compare the incidence of AKI after elective EVAR conducted under general anesthesia with and without administration of dexmedetomidine. The AKI will be evaluated through measuring NGAL and c-cystatin.
- Being tested
- Dexmedetomidine
- Keywords
- Acute kidney injury, Dexmedetomidine, EVAR
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Administration of dexmedetomidine intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| DEXMEDETOMIDINE AND AKI | Active comparator | The patients of the group undergoing EVAR under general anesthesia will receive dexmedetomidine intraoperatively. Receives: Drug: Dexmedetomidine |
| CONTROL AND AKI | No intervention | The patients of the group undergoing EVAR under general anesthesia will not receive dexmedetomidine intraoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Kidney Injury
Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine
Measured: 1st Postoperative Day
Secondary outcomes (3)
Incidence of postoperative ICU admission
Record the incidence of unanticipated postoperative ICU admission
Measured: Operation day to 5th postoperative day
Incidence of arrhythmia
Record the incidence of arrhythmia postoperatively
Measured: Up to 24 hours after surgery
Incidence of Postoperative Delirium
Record the incidence of Postoperative Delirium postoperatively
Measured: Operation day to 4th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start30 Aug 2021 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, MD, PhD, Study chair, University of ThessalyKonstantinos Stamoulis, MD, PhD, Principal investigator, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766047
- Sponsor's protocol ID
- Dexmedetomidine in EVAR
- Acronym
- DEVAR
- Status last verified
- Apr 2021
- First submitted
- 2 Feb 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on the Incidence of Acute Kidney Injury in EVAR
- ClinicalTrials.gov ID
- NCT04766047
- Acronym / sponsor ID
- DEVAR / Dexmedetomidine in EVAR
- Keywords
- Acute kidney injury, Dexmedetomidine, EVAR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 30 Aug 2021 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 23 Feb 2021 (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.
This study will investigate the effect of dexmedetomidine on the incidence of postoperative acute kidney injury in patients undergoing EVAR under general anesthesia
Detailed description
This study will compare the incidence of AKI after elective EVAR conducted under general anesthesia with and without administration of dexmedetomidine. The AKI will be evaluated through measuring NGAL and c-cystatin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEXMEDETOMIDINE AND AKI | Active comparator | Drug: DexmedetomidineThe patients of the group undergoing EVAR under general anesthesia will receive dexmedetomidine intraoperatively. |
| CONTROL AND AKI | No intervention | –The patients of the group undergoing EVAR under general anesthesia will not receive dexmedetomidine intraoperatively. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective EVAR under general anesthesia
- adult patients 18- 85 years old
- American society of anesthesiologists (ASA) physical status I - IV
Key exclusion criteria (6 listed)
- refusal to participate or sign the informed consent form
- GFR < 50ml/mim
- Bradyarrhythmia <50/min
- Hemodynamic instability
- Known allergy to Dexmedetomidine
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 |
|---|---|---|
| DexmedetomidineAdministration of dexmedetomidine intraoperatively | Drug | DEXMEDETOMIDINE AND AKI |
Primary outcome
Incidence of Acute Kidney Injury
Time frame: 1st Postoperative Day
Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine
3 secondary outcomes
Incidence of postoperative ICU admission
Time frame: Operation day to 5th postoperative day
Incidence of arrhythmia
Time frame: Up to 24 hours after surgery
Incidence of Postoperative Delirium
Time frame: Operation day to 4th postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- 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.
Eleni Arnaoutoglou, MD, PhD study chair
University of Thessaly
Konstantinos Stamoulis, MD, PhD principal investigator
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Acute Kidney Injury and Dexmedetomidine, run by University of Thessaly at 1 site in Greece.
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 6 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleni Arnaoutoglou, MD, PhD (+306974301352, earnaout@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Kidney Injury (time frame: 1st Postoperative Day). 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 28 Apr 2021.