Angiotensin II Pathway and Acute Lung Injury

• Sponsor: Beijing Anzhen Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05055570
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 21.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Acute type A aortic dissection is often accompanied by postoperative pulmonary complications, 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 pulmonary complications after acute type A aortic dissection, and to provide reference for clinical application

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Mechanism Research of Angiotensin II Pathway and Acute Lung Injury
• Actual Study Start Date: Aug 12, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Hypoxemia group oxygenation index (OI)≤200	Other: No intervention; No intervention
Non-hypoxemia group oxygenation index (OI)>200	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. The difference concentrations of Ang II，ACE2 and miR-145 in serum between patients with and without postoperative hypoxemia. [Within 24 hours after surgery]

   Blood samples were taken within 24 hours after operation to detect the contents of Ang II, ACE2 and miR-145 in serum.

Secondary Outcome Measures

1. The risk factors for postoperative hypoxemia in Stanford type A acute aortic dissection patients. [up to 60 days]

   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.

2. Duration of Stay in the Intensive Care Unit [up to 60 days]

   Duration of Stay in the intensive care unit after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients undergoing surgery for acute type A aortic dissection

• age between 18 to 80

Exclusion Criteria:

• perioperative severe cardiac insufficiency

• rejection of consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anzhen hospital, Beijing	Beijing	Beijing	China	100029

Sponsors and Collaborators

• Beijing Anzhen Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Ma, The chief of department of anesthesiology, Beijing Anzhen Hospital
• ClinicalTrials.gov Identifier: NCT05055570
• Other Study ID Numbers: 2021107X
• First Posted: Sep 24, 2021
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Injury; Acute Lung Injury; Aneurysm, Dissecting

Study Results

No Results Posted as of Aug 3, 2022