Biomarkers in Thoracic Aorta Surgery

• Sponsor: Petrovsky National Research Centre of Surgery (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04689139
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

Biomarkers can play a vital role in prognosing the perioperative complications in thoracic aorta surgery. The goal of a study is to determine the correlation between intraoperative level of certain biomarkers and total amount of peroperative complications.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm; Thoracoabdominal Aneurysm; Aortic Dissection; Complication	Diagnostic Test: blood sample tests for determination of biomarkers levels	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Role of Intraoperative Biomarkers in Prognosis of Perioperative Complications in Reconstructive Thoracic Aorta Surgery
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thoracic aorta surgery patients Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired	Diagnostic Test: blood sample tests for determination of biomarkers levels; Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.

Outcome Measures

Primary Outcome Measures

1. Postoperative complications [up to 10 days]

   Total amount of various postoperative complications

Secondary Outcome Measures

1. Mortality [up to 10 days]

   mortality rate

2. Multiorgan failure [up to 10 days]

   Number of more than 2 organs failure

3. Respiratory failure [up to 10 days]

   Number of patients who require prolonged and/or repeated artificial lung ventilation

4. Renal failure [up to 10 days]

   Number of patients who require extracorporeal detoxication

5. Heart failure [up to 10 days]

   Need in medicamental cardiotonic support more than 1 day

6. Circulatory insufficiency [up to 10 days]

   Need in medicamental vasopressor support more than 1 day

7. Infection rate [up to 10 days]

   Number of patients who develop systemic infection and/or operation wound infection

8. Length of intensive care stay [up to 10 days]

   Duration of summarized length in ICU, including readmission to ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective thoracic and thoracoabdominal surgery

Exclusion Criteria:

• Hemolysis in blood sample

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)	Moscow		Russian Federation	119991

Sponsors and Collaborators

• Petrovsky National Research Centre of Surgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Petrovsky National Research Centre of Surgery
• ClinicalTrials.gov Identifier: NCT04689139
• Other Study ID Numbers: 039420200002
• First Posted: Dec 30, 2020
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aneurysm, Dissecting

Study Results

No Results Posted as of Sep 16, 2021