Acute Ischemic StrokePhase 4NCT04916197
Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
A Phase 4 study testing Dexmedetomidine prolonged sedation and 0.9% saline in people with Acute Ischemic Stroke, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Dexmedetomidine prolonged sedation and 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2≤NIHSS≤25
- mRS score before stroke was less than 3
- Acute ischemic stroke (including anterior circulation)
- mTICI rate 2b or 3
- According to the 2018 AHA/ASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation
- Informed consent was signed by patient or legal representative
Who cannot join
- Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks
- Patients who had received stent treatment at the responsible vessel in the past
- Neurological function was restored at or before angiography
- Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications
- Hemoglobin was less than 70g/L, platelet count was less than 50×109/L, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors
- Blood glucose < 2.7 mmol/L or > 22.2 mmol/L
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- Severe liver or kidney disfunction, ALT>3 times the upper limit of normal value or AST>3 times the upper limit of normal value, creatinine>1.5 times the upper limit of normal value
- Pregnant or lactating women
- Previous history of mental illness
- Stroke with other acute diseases or postoperative stroke of other operation
- Heart rate less than 50bpm, second or third degree of atrioventricular block (except for pacemaker implantation), systolic blood pressure less than 90mmHg (two vasoactive drugs were already infused continuously )
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, 100020
Lina Yang, 18611635556, Thoth_safin@sina.com
About this study
Official title: Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.
Read the detailed description
Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.
Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke.
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury.
The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Dexmedetomidine prolonged sedation, 0.9% saline
- Keywords
- Endovascular thrombectomy, Dexmedetomidine, Modified Rankin Scale
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine prolonged sedationDrug
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
0.9% salineDrug
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3. Receives: Drug: Dexmedetomidine prolonged sedation |
| Control group | Placebo comparator | An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3. Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The favorable functional outcome of stroke-related disability rate
Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.
Measured: 90 ± 14 days after thrombectomy
Secondary outcomes (7)
Changes of National Institute of Health stroke scale
NIHSS (admission) - NIHSS (24h)
Measured: 24 ± 6 hours after thrombectomy
Changes of National Institute of Health stroke scale
NIHSS (admission) - NIHSS (7day)
Measured: on the 7-day or discharged day whichever comes first, up to 30 days
Changes of ischemic penumbra
The difference of infarct volume between preoperative and 7-day or discharged day
Measured: on the 7-day or discharged day whichever comes first, up to 30 days
Length of ICU stay
Length of ICU stay
Measured: From the date of admission until discharged from ICU, up to 30 days
Length of hospital stay
Length of hospital stay
Measured: From the date of admission until discharged from hospital, up to 30 days
adverse events at 90-day after operation
hypotension (systolic blood pressure under 90mmHg), bradycardia (heart rate under 50bpm), hypoxemia (pulse oxygen saturation under 90%), and serious events such as death and life-threatening events
Measured: within 90-day after thrombectomy
mortality rate at 90-day after operation
Death after thrombectomy within 90-day after operation
Measured: within 90-day after thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Mar 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changwei Wei, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916197
- Sponsor's protocol ID
- 00375929
- Status last verified
- Dec 2023
- First submitted
- 25 May 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and Informed Consent Form will be shared with other researchers.
Publications
Yang LN, Sun Y, Wang YZ, Wang J, Qi YS, Mu SS, Liu YP, Zhang ZQ, Chen ZM, Wang XJ, Xie WX, Wei CW, Wang Y, Wu AS. Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial. Trials. 2024 Mar 4;25(1):166. doi: 10.1186/s13063-024-08015-x.
PubMed 38439027
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)
- ClinicalTrials.gov ID
- NCT04916197
- Acronym / sponsor ID
- 00375929
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular thrombectomy, Dexmedetomidine, Modified Rankin Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jun 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.
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.
Detailed description
Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.
Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke.
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury.
The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Dexmedetomidine prolonged sedationDexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3. |
| Control group | Placebo comparator | Drug: 0.9% salineAn equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 2≤NIHSS≤25
- mRS score before stroke was less than 3
- Acute ischemic stroke (including anterior circulation)
- mTICI rate 2b or 3
- According to the 2018 AHA/ASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation
Key exclusion criteria (11 listed)
- Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks
- Patients who had received stent treatment at the responsible vessel in the past
- Neurological function was restored at or before angiography
- Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications
- Hemoglobin was less than 70g/L, platelet count was less than 50×109/L, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors
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 |
|---|---|---|
| Dexmedetomidine prolonged sedationDexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU. | Drug | Intervention group |
| 0.9% salineAn equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU. | Drug | Control group |
Primary outcome
The favorable functional outcome of stroke-related disability rate
Time frame: 90 ± 14 days after thrombectomy
Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.
7 secondary outcomes
Changes of National Institute of Health stroke scale
Time frame: 24 ± 6 hours after thrombectomy
Changes of National Institute of Health stroke scale
Time frame: on the 7-day or discharged day whichever comes first, up to 30 days
Changes of ischemic penumbra
Time frame: on the 7-day or discharged day whichever comes first, up to 30 days
Length of ICU stay
Time frame: From the date of admission until discharged from ICU, up to 30 days
Length of hospital stay
Time frame: From the date of admission until discharged from hospital, up to 30 days
adverse events at 90-day after operation
Time frame: within 90-day after thrombectomy
mortality rate at 90-day after operation
Time frame: within 90-day after thrombectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 38439027Yang LN, Sun Y, Wang YZ, Wang J, Qi YS, Mu SS, Liu YP, Zhang ZQ, Chen ZM, Wang XJ, Xie WX, Wei CW, Wang Y, Wu AS. Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial. Trials. 2024 Mar 4;25(1):166. doi: 10.1186/s13063-024-08015-x.
- Individual participant dataSharing planned: Yes. The study protocol and Informed Consent Form will be shared with other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine prolonged sedation and 0.9% saline in people with Acute Ischemic Stroke, run by Beijing Chao Yang Hospital at 1 site in China.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 20 Dec 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Yang (18611635556, Thoth_safin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The favorable functional outcome of stroke-related disability rate (time frame: 90 ± 14 days after thrombectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916197, which also lists 1 linked publication.
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 20 Dec 2023.