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NCT04689139 Clinical Trial

Biomarkers in Thoracic Aorta Surgery

Aortic Aneurysm Clinical Trial

Official title:
Role of Intraoperative Biomarkers in Prognosis of Perioperative Complications in Reconstructive Thoracic Aorta Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04689139
Other study ID # 039420200002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date May 1, 2022

Study information
Verified date November 2023
Source Petrovsky National Research Centre of Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

This study aims to assess the association between levels of biomarkers and postoperative complications in patients after thoracic and thoracoabdominal aortic reconstruction.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date May 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Elective thoracic and thoracoabdominal surgery Exclusion Criteria: - Hemolysis in blood sample

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Russian Federation Petrovsky Research National Centre of Surgery ( Petrovsky NRCS) Moscow

Sponsors (1)
Lead Sponsor Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Complications Total amount of various postoperative complications up to 10 days
Secondary Mortality mortality rate up to 10 days
Secondary Renal Failure Number of patients who require extracorporeal detoxication up to 10 days
Secondary Heart Failure Need in medicamental cardiotonic support more than 1 day up to 10 days
Secondary Circulatory Insufficiency Need in medicamental vasopressor support more than 1 day up to 10 days
Secondary Infection Rate Number of patients who develop systemic infection and/or operation wound infection up to 10 days
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