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Biomarkers in Thoracic Aorta Surgery

Primary Purpose

Aortic Aneurysm, Thoracoabdominal Aneurysm, Aortic Dissection

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
blood sample tests for determination of biomarkers levels
Sponsored by
Petrovsky National Research Centre of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aortic Aneurysm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective thoracic and thoracoabdominal surgery

Exclusion Criteria:

  • Hemolysis in blood sample

Sites / Locations

  • Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thoracic aorta surgery patients

Arm Description

Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired

Outcomes

Primary Outcome Measures

Postoperative complications
Total amount of various postoperative complications

Secondary Outcome Measures

Mortality
mortality rate
Multiorgan failure
Number of more than 2 organs failure
Respiratory failure
Number of patients who require prolonged and/or repeated artificial lung ventilation
Renal failure
Number of patients who require extracorporeal detoxication
Heart failure
Need in medicamental cardiotonic support more than 1 day
Circulatory insufficiency
Need in medicamental vasopressor support more than 1 day
Infection rate
Number of patients who develop systemic infection and/or operation wound infection
Length of intensive care stay
Duration of summarized length in ICU, including readmission to ICU

Full Information

First Posted
December 22, 2020
Last Updated
September 27, 2022
Sponsor
Petrovsky National Research Centre of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT04689139
Brief Title
Biomarkers in Thoracic Aorta Surgery
Official Title
Role of Intraoperative Biomarkers in Prognosis of Perioperative Complications in Reconstructive Thoracic Aorta Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Petrovsky National Research Centre of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracoabdominal Aneurysm, Aortic Dissection, Complication

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic aorta surgery patients
Arm Type
Experimental
Arm Description
Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired
Intervention Type
Diagnostic Test
Intervention Name(s)
blood sample tests for determination of biomarkers levels
Intervention Description
Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
Total amount of various postoperative complications
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
Mortality
Description
mortality rate
Time Frame
up to 10 days
Title
Multiorgan failure
Description
Number of more than 2 organs failure
Time Frame
up to 10 days
Title
Respiratory failure
Description
Number of patients who require prolonged and/or repeated artificial lung ventilation
Time Frame
up to 10 days
Title
Renal failure
Description
Number of patients who require extracorporeal detoxication
Time Frame
up to 10 days
Title
Heart failure
Description
Need in medicamental cardiotonic support more than 1 day
Time Frame
up to 10 days
Title
Circulatory insufficiency
Description
Need in medicamental vasopressor support more than 1 day
Time Frame
up to 10 days
Title
Infection rate
Description
Number of patients who develop systemic infection and/or operation wound infection
Time Frame
up to 10 days
Title
Length of intensive care stay
Description
Duration of summarized length in ICU, including readmission to ICU
Time Frame
up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective thoracic and thoracoabdominal surgery Exclusion Criteria: Hemolysis in blood sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Akselrod, Professor
Organizational Affiliation
Petrovsky NRCS
Official's Role
Study Director
Facility Information:
Facility Name
Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Biomarkers in Thoracic Aorta Surgery

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