Aortic DissectionNCT05055570

Angiotensin II Pathway and Postoperative Hypoxemia

An observational study of Aortic Dissection, run by Beijing Anzhen Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Aortic Dissection
How many people: 88 participants
Where: 1 siteChina
Study dates: 12 Aug 2021to 1 Jun 2022
How long will I take part?: 7 Days
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Patients undergoing surgical treatment for acute type A aortic dissection in our hospital were selected. The age was 18 years ≤ age ≤80years, and gender was not limited. The overall study patients were divided into the hypoxemia group and non-hypoxemia group according to the presence or lack of hypoxemia after surgery.

Who may be able to join

patients undergoing surgery for acute type A aortic dissection
age between 18 to 80

Who cannot join

perioperative severe cardiac insufficiency
rejection of consent

Trial locations and contacts

1 site in 1 country.

China1 site

Anzhen hospital, Beijing
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: The Mechanism Research of Angiotensin II Pathway and Postoperative Hypoxemia

Acute type A aortic dissection is often accompanied by postoperative hypoxemia, the cause of which is not fully understood. Angiotensin II is an important component of the renin-angiotensin system (RAS), which has been suggested to be involved in the development of aortic dissection and pulmonary inflammation.The purpose of this study was to investigate the role and mechanism of angiotensin II pathway in postoperative hypoxemia after acute type A aortic dissection, and to provide reference for clinical application

Conditions: Aortic Dissection
Being tested: No intervention
Medical subject headings: Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
No intervention

Study groups in NCT05055570
Study group	Role	What they receive
Hypoxemia group		oxygenation index (OI)≤200 Receives: Other: No intervention
Non-hypoxemia group		oxygenation index (OI)>200 Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

The Difference Concentrations of ANG II in Serum Between Patients With and Without Postoperative Hypoxemia.
Blood samples were taken within 24 hours after operation to detect the contents of ANG II in serum. Postoperative hypoxemia is defined by the oxygenation index (OI), which is the ratio of arterial partial pressure of oxygen to fraction inspired oxygen (PaO2 / FiO2), of less than or equal to 200 for two consecutive times within the first 24 h after operation
Measured: Within 24 hours after surgery

Secondary outcomes (2)

The Risk Factors for Postoperative Hypoxemia in Stanford Type A Acute Aortic Dissection Patients.
Basic characteristics, intraoperative details, biochemical parameters and outcome results were obtained, and blood was collected within 24 hours after surgery for the measurement of ANG II, sACE2 and mir-145 concentrations. Univariate analysis was first performed to identify the potential risk factors for postoperative hypoxemia. Multivariate logistic regression analysis was performed for factors with P < 0.05 or that were considered clinically important.
Measured: up to 60 days
Duration of Stay in the Intensive Care Unit
Duration of Stay in the intensive care unit after surgery
Measured: up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 20211 Jun 2022

First posted24 Sep 2021
Study start12 Aug 2021
Primary completion1 Jun 2022
Study completion1 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aortic DissectionStudies 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: Cohort
Time perspective: Prospective
Enrolment: 88 participants (actual)
Target duration: 7 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT05055570
Sponsor's protocol ID: 2021107X
Status last verified: Apr 2023
First submitted: 7 Sep 2021
Last updated: 26 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wang X, Ma J, Lin D, Dong X, Wu J, Bai Y, Zhang D, Gao J. The risk factors of postoperative hypoxemia in patients with Stanford type A acute aortic dissection. Medicine (Baltimore). 2023 Aug 18;102(33):e34704. doi: 10.1097/MD.0000000000034704.
PubMed 37603505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

All Aortic Dissection trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Mechanism Research of Angiotensin II Pathway and Postoperative Hypoxemia
ClinicalTrials.gov ID: NCT05055570
Acronym / sponsor ID: 2021107X
Conditions: Aortic Dissection
Study type: Observational
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Beijing Anzhen HospitalUniversity, hospital or other
Study start: 12 Aug 2021 (actual)
Primary completion: 1 Jun 2022 (actual)
Study completion: 1 Jun 2022 (actual)
First posted: 24 Sep 2021 (actual)
Results: Posted 26 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 7 Days
Number of arms: 2

Arm	Type	Receives
Hypoxemia group	–	Other: No interventionoxygenation index (OI)≤200
Non-hypoxemia group	–	Other: No interventionoxygenation index (OI)>200

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing surgical treatment for acute type A aortic dissection in our hospital were selected. The age was 18 years ≤ age ≤80years, and gender was not limited. The overall study patients were divided into the hypoxemia group and non-hypoxemia group according to the presence or lack of hypoxemia after surgery.

Key inclusion criteria (2 listed)

patients undergoing surgery for acute type A aortic dissection
age between 18 to 80

Key exclusion criteria (2 listed)

perioperative severe cardiac insufficiency
rejection of consent

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
No interventionNo intervention	Other	Hypoxemia group, Non-hypoxemia group

Primary outcome

The Difference Concentrations of ANG II in Serum Between Patients With and Without Postoperative Hypoxemia.
Time frame: Within 24 hours after surgery
Blood samples were taken within 24 hours after operation to detect the contents of ANG II in serum. Postoperative hypoxemia is defined by the oxygenation index (OI), which is the ratio of arterial partial pressure of oxygen to fraction inspired oxygen (PaO2 / FiO2), of less than or equal to 200 for two consecutive times within the first 24 h after operation

2 secondary outcomes

The Risk Factors for Postoperative Hypoxemia in Stanford Type A Acute Aortic Dissection Patients.
Time frame: up to 60 days
Duration of Stay in the Intensive Care Unit
Time frame: up to 60 days

Results and safety

Results posted to the registry on 26 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hypoxemia Group	25	25
Non-hypoxemia Group	63	63

Primary outcome: The Difference Concentrations of ANG II in Serum Between Patients With and Without Postoperative Hypoxemia.

Time frame: Within 24 hours after surgery. Median (Inter-Quartile Range). Unit: pg / mL

Measure	Hypoxemia Group n = 25	Non-hypoxemia Group n = 63
Value	100 (73.9 to 117.6)	78.5 (60.9 to 92.1)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: One month after surgery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypoxemia Group	0 of 25 (0%)	0 of 25 (0%)	1 of 25
Non-hypoxemia Group	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37603505Wang X, Ma J, Lin D, Dong X, Wu J, Bai Y, Zhang D, Gao J. The risk factors of postoperative hypoxemia in patients with Stanford type A acute aortic dissection. Medicine (Baltimore). 2023 Aug 18;102(33):e34704. doi: 10.1097/MD.0000000000034704.

Related trials for Aortic Dissection

Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Dissection, run by Beijing Anzhen 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 2 inclusion and 2 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 26 Jan 2024. 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. 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?

Yes. Results are posted in the registry (first posted 26 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Difference Concentrations of ANG II in Serum Between Patients With and Without Postoperative Hypoxemia. (time frame: Within 24 hours after surgery). 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 NCT05055570, 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 26 Jan 2024.