Aneurysm AbdominalPhase 4DEPOSNCT06044480
Effect of Dexamethason on Postimplantation Syndrome After EVAR
A Phase 4 study testing Dexamethasone in people with Aneurysm Abdominal and Endovascular Aneurysm Repair, run by Centro Hospitalar de Lisboa Central.
Trial summary
This study is a multi center double-blinded randomized controlled superiority trial, comparing the effects on postimplantatrion syndrome of a single preoperative dose of dexamethasone vs. standard treatment in endovascular aneurysm repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Abdominal, Endovascular Aneurysm Repair, Postimplantation Syndrome
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 May 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Elective treatment for a degenerative infrarenal abdominal aortic aneurysm by implantation of an endograft
- Additional procedures, as endoanchors, proximal extension with a cuff or iliac branch device, during primary EVAR are allowed.
Who cannot join
- Mycotic aneurysms, aortic dissections and inflammatory aneurysms
- Known inflammatory or infectious diseases
- Preoperative anti-inflammatory therapeutic
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Preoperative Dexamethasone on Postimplantation Syndrome After Endovascular Aneurysm Repair - Protocol for a Randomized Controlled Trial
This study is a multi center double-blinded randomized controlled superiority trial, comparing the effects on postimplantatrion syndrome of a single preoperative dose of dexamethasone vs. standard treatment in endovascular aneurysm repair. Participating researchers must be vascular surgeons or vascular anesthesiologists certified by national entities. Recruitment is expected to begin in the second semester of 2023.
The trial will follow the ICH-GCP guidelines and national and international legislation and reporting will be performed according to CONSORT 2010 guidelines. Site inclusion requires hospital ethics committee approval. Written informed consent is mandatory for all patients and the information and consent forms must be approved by Institutional Ethics Committee.
Read the detailed description
Post-Implantation Syndrome (PIS) consists on an inflammatory reaction after endovascular aneurysm repair of abdominal aortic aneurysms (EVAR) whose etiology and pathophysiology is still unclear, but is characterized by flu-like symptoms, with fever and elevation of analytical inflammatory parameters in the postoperative period. It is associated with a length of hospital stay and there are some studies that indicate an association with lower quality of life, increase in cardiovascular complications up to one year later and aneurysm-related complications.
PIS is defined by the presence of two criteria: tympanic temperature greater than 38ºC and CRP greater than 75 mg/L in the first three postoperative days.
Dexamethasone was the selected glucocorticoid, since it has virtually no action mineralocorticoid, has been tested in the perioperative context and is administered frequently in this context, namely at CHULC. Its use is intended to reduce symptoms associated with orotracheal extubation, pain, nausea and quality of life, without adverse effects relevant associates.
Study hypothesis: A single dose of 4mg dose of intravenous dexamethasone administered 30 minutes before surgery reduces the incidence and magnitude of PIS after EVAR.
Elegibility criteria: All the patients treated electively for a degenerative infrarenal abdominal aortic aneurysm by implantation of an endograft are eligible for this study. Patients treated for mycotic aneurysms, aortic dissections and inflammatory aneurysms are not eligible for this study, as well as patients with known inflammatory or infectious diseases and/or preoperative anti-inflammatory therapeutic.
If additional procedures, as endoanchors, proximal extension with a cuff or iliac branch device, are performed during primary EVAR, the patients should be enrolled.
Primary endpoints: The chosen primary endpoint is the occurrence of postimplantation syndrome, which is defined as fever (auricular temperature >38ºC) and elevation of CRP (> 75 mg/L), during the first 3 days after operation.
Secondary endpoints Efficacy endpoints are length of hospital stay, cardiovascular events, AAA-related complications and quality of life at 30 days and one year.
Safety endpoints relate to potential side effects of dexamethasone, as taste disturbances, hyperglycemia, flushing, rise in blood pressure, palpitations, headache, sleep isturbances,depression,euphoria, bradycardia, and cardiac decompensation in the first 30 days after operation.
- Conditions
- Aneurysm Abdominal, Endovascular Aneurysm Repair, Postimplantation Syndrome, Dexamethasone
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Administration of a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation.
PlaceboOther
Administration of the same amount of saline solution instead of dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Active comparator | This group of participans will be submitted to a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation. Receives: Drug: Dexamethasone |
| placebo | Placebo comparator | This group of patients will be submitted to a same amount of saline solution. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postimplantation syndrome incidence
Occurrence of postimplantation syndrome, which is defined as fever (auricular temperature >38ºC) and elevation of CRP (> 75 mg/L), during the first 3 days after operation.
Measured: 3 days after surgery
Secondary outcomes (5)
Length of hospital stay (days)
Efficacy outcome
Measured: 1 year
cardiovascular events
Efficacy outcome
Measured: 1 year
Rate of AAA-related complications
Efficacy outcome
Measured: 1 year
Quality of life (EQ-5D)
Efficacy outcome
Measured: 1 year
Safety outcomes
Rate of side effects of dexamethasone
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm AbdominalStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Lisboa Central
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044480
- Sponsor's protocol ID
- CHULC.CI.110.2020
- Acronym
- DEPOS
- Status last verified
- Jun 2023
- First submitted
- 19 Jun 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Dexamethasone on Postimplantation Syndrome After Endovascular Aneurysm Repair - Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06044480
- Acronym / sponsor ID
- DEPOS / CHULC.CI.110.2020
- Conditions
- Aneurysm Abdominal, Endovascular Aneurysm Repair, Postimplantation Syndrome, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Lisboa CentralUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Sep 2023 (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 is a multi center double-blinded randomized controlled superiority trial, comparing the effects on postimplantatrion syndrome of a single preoperative dose of dexamethasone vs. standard treatment in endovascular aneurysm repair. Participating researchers must be vascular surgeons or vascular anesthesiologists certified by national entities. Recruitment is expected to begin in the second semester of 2023.
The trial will follow the ICH-GCP guidelines and national and international legislation and reporting will be performed according to CONSORT 2010 guidelines. Site inclusion requires hospital ethics committee approval. Written informed consent is mandatory for all patients and the information and consent forms must be approved by Institutional Ethics Committee.
Detailed description
Post-Implantation Syndrome (PIS) consists on an inflammatory reaction after endovascular aneurysm repair of abdominal aortic aneurysms (EVAR) whose etiology and pathophysiology is still unclear, but is characterized by flu-like symptoms, with fever and elevation of analytical inflammatory parameters in the postoperative period. It is associated with a length of hospital stay and there are some studies that indicate an association with lower quality of life, increase in cardiovascular complications up to one year later and aneurysm-related complications.
PIS is defined by the presence of two criteria: tympanic temperature greater than 38ºC and CRP greater than 75 mg/L in the first three postoperative days.
Dexamethasone was the selected glucocorticoid, since it has virtually no action mineralocorticoid, has been tested in the perioperative context and is administered frequently in this context, namely at CHULC. Its use is intended to reduce symptoms associated with orotracheal extubation, pain, nausea and quality of life, without adverse effects relevant associates.
Study hypothesis: A single dose of 4mg dose of intravenous dexamethasone administered 30 minutes before surgery reduces the incidence and magnitude of PIS after EVAR.
Elegibility criteria: All the patients treated electively for a degenerative infrarenal abdominal aortic aneurysm by implantation of an endograft are eligible for this study. Patients treated for mycotic aneurysms, aortic dissections and inflammatory aneurysms are not eligible for this study, as well as patients with known inflammatory or infectious diseases and/or preoperative anti-inflammatory therapeutic.
If additional procedures, as endoanchors, proximal extension with a cuff or iliac branch device, are performed during primary EVAR, the patients should be enrolled.
Primary endpoints: The chosen primary endpoint is the occurrence of postimplantation syndrome, which is defined as fever (auricular temperature >38ºC) and elevation of CRP (> 75 mg/L), during the first 3 days after operation.
Secondary endpoints Efficacy endpoints are length of hospital stay, cardiovascular events, AAA-related complications and quality of life at 30 days and one year.
Safety endpoints relate to potential side effects of dexamethasone, as taste disturbances, hyperglycemia, flushing, rise in blood pressure, palpitations, headache, sleep isturbances,depression,euphoria, bradycardia, and cardiac decompensation in the first 30 days after operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Active comparator | Drug: DexamethasoneThis group of participans will be submitted to a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation. |
| placebo | Placebo comparator | Other: PlaceboThis group of patients will be submitted to a same amount of saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective treatment for a degenerative infrarenal abdominal aortic aneurysm by implantation of an endograft
- Additional procedures, as endoanchors, proximal extension with a cuff or iliac branch device, during primary EVAR are allowed.
Key exclusion criteria (3 listed)
- Mycotic aneurysms, aortic dissections and inflammatory aneurysms
- Known inflammatory or infectious diseases
- Preoperative anti-inflammatory therapeutic
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 |
|---|---|---|
| DexamethasoneAdministration of a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation. | Drug | dexamethasone |
| PlaceboAdministration of the same amount of saline solution instead of dexamethasone | Other | placebo |
Primary outcome
Postimplantation syndrome incidence
Time frame: 3 days after surgery
Occurrence of postimplantation syndrome, which is defined as fever (auricular temperature >38ºC) and elevation of CRP (> 75 mg/L), during the first 3 days after operation.
5 secondary outcomes
Length of hospital stay (days)
Time frame: 1 year
cardiovascular events
Time frame: 1 year
Rate of AAA-related complications
Time frame: 1 year
Quality of life (EQ-5D)
Time frame: 1 year
Safety outcomes
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Aneurysm Abdominal and Endovascular Aneurysm Repair, run by Centro Hospitalar de Lisboa Central.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rita Ferreira, MD (+351213594000, rita.sferreira33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postimplantation syndrome incidence (time frame: 3 days after surgery). 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 21 Sep 2023.