NCT05055570

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 26, 2024

Completed
Last Updated

January 26, 2024

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

September 7, 2021

Results QC Date

April 24, 2023

Last Update Submit

April 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Within 24 hours after surgery

Secondary Outcomes (2)

  • The Risk Factors for Postoperative Hypoxemia in Stanford Type A Acute Aortic Dissection Patients.

    up to 60 days

  • Duration of Stay in the Intensive Care Unit

    up to 60 days

Study Arms (2)

Hypoxemia group

oxygenation index (OI)≤200

Other: No intervention

Non-hypoxemia group

oxygenation index (OI)\>200

Other: No intervention

Interventions

No intervention

Hypoxemia groupNon-hypoxemia group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • perioperative severe cardiac insufficiency
  • rejection of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anzhen hospital, Beijing

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Results Point of Contact

Title
Dr. Jun Ma
Organization
Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The chief of department of anesthesiology

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 24, 2021

Study Start

August 12, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

January 26, 2024

Results First Posted

January 26, 2024

Record last verified: 2023-04

Locations