Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion InjuryNCT05151536
Effects of Different Doses of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection
An observational study of Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion Injury, run by Yunlong Fan.
Trial summary
Aortic dissection is the most common aortic disease leading to death. Among them, patients with Stanford type A dissection (TAAD) are prone to dissection rupture in the early stage, and their condition deteriorates rapidly. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion Injury
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jan 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The TAAD patients aged 18-75 years old
Who may be able to join
- The patient's age was 18-75 years old; TAAD was diagnosed by aortic CTA before operation; Sun's operation was performed within two weeks of onset; Deep hypothermic circulatory arrest (DHCA) and selective unilateral cerebral perfusion via right axillary artery were used for brain protection; Adrenaline was used after operation
Who cannot join
- Nervous system disease and mental system disease before operation; Recent acute coronary syndrome; Recent cardiac arrest; Recent poor perfusion of visceral or peripheral organs; Recent hypoxemia; Previous history of cardiac surgery; Intraoperative death and death within 48 hours after operation; Neurological or psychiatric symptoms occurred within 48 hours after operation; Adrenaline was not used after operation
About this study
Official title: To Explore the Impact of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection
Aortic dissection is the most common aortic disease leading to death. Among them, patients with Stanford type A dissection (TAAD) are prone to dissection rupture in the early stage, and their condition deteriorates rapidly. They need immediate surgical treatment after admission.In this study, the detection data of biomarkers of nervous system Ischemia / Reperfusion (I/R)injury in patients with Stanford type A dissection were retrospectively analyzed, and the effects of different doses of adrenaline on biomarkers of nervous system I/R injury were evaluated by statistical methods.The information of 132 patients with Stanford type A aortic dissection who underwent sun's operation in the Department of cardiovascular surgery of the first medical center of the PLA General Hospital from January 2012 to January 2019 was retrospectively analyzed.
- Medical subject headings
- Aortic Dissection, Neurologic Manifestations, Reperfusion Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of nervous system ischemia-reperfusion injury
Monoamine oxidase, superoxide dismutase, interleukin-6, tumor necrosis factor- α
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jan 2012
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion InjuryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yunlong Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunlong Fan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151536
- Sponsor's protocol ID
- chinaPLAGH-66936749
- Status last verified
- Nov 2021
- First submitted
- 28 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Impact of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection
- ClinicalTrials.gov ID
- NCT05151536
- Acronym / sponsor ID
- chinaPLAGH-66936749
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Yunlong FanUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 9 Dec 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.
Aortic dissection is the most common aortic disease leading to death. Among them, patients with Stanford type A dissection (TAAD) are prone to dissection rupture in the early stage, and their condition deteriorates rapidly. They need immediate surgical treatment after admission.In this study, the detection data of biomarkers of nervous system Ischemia / Reperfusion (I/R)injury in patients with Stanford type A dissection were retrospectively analyzed, and the effects of different doses of adrenaline on biomarkers of nervous system I/R injury were evaluated by statistical methods.The information of 132 patients with Stanford type A aortic dissection who underwent sun's operation in the Department of cardiovascular surgery of the first medical center of the PLA General Hospital from January 2012 to January 2019 was retrospectively analyzed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The TAAD patients aged 18-75 years old
Key inclusion criteria (1 listed)
- The patient's age was 18-75 years old; TAAD was diagnosed by aortic CTA before operation; Sun's operation was performed within two weeks of onset; Deep hypothermic circulatory arrest (DHCA) and selective unilateral cerebral perfusion via right axillary artery were used for brain protection; Adrenaline was used after operation
Key exclusion criteria (1 listed)
- Nervous system disease and mental system disease before operation; Recent acute coronary syndrome; Recent cardiac arrest; Recent poor perfusion of visceral or peripheral organs; Recent hypoxemia; Previous history of cardiac surgery; Intraoperative death and death within 48 hours after operation; Neurological or psychiatric symptoms occurred within 48 hours after operation; Adrenaline was not used after operation
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
Biomarkers of nervous system ischemia-reperfusion injury
Time frame: 24 hours
Monoamine oxidase, superoxide dismutase, interleukin-6, tumor necrosis factor- α
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 9 Dec 2021.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion Injury, run by Yunlong Fan.
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 1 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 9 Dec 2021. 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?
Biomarkers of nervous system ischemia-reperfusion injury (time frame: 24 hours). 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 9 Dec 2021.