Biomarkers in Thoracic Aorta Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Complication; Aortic Aneurysm; Aortic Dissection; Thoracoabdominal Aneurysm
• Intervention / Treatment: Diagnostic test: blood sample tests for determination of biomarkers levels

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective thoracic and thoracoabdominal surgery

Exclusion Criteria:

• Hemolysis in blood sample

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Total amount of various postoperative complications	up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	mortality rate	up to 10 days
Multiorgan failure	Number of more than 2 organs failure	up to 10 days
Respiratory failure	Number of patients who require prolonged and/or repeated artificial lung ventilation	up to 10 days
Renal failure	Number of patients who require extracorporeal detoxication	up to 10 days
Heart failure	Need in medicamental cardiotonic support more than 1 day	up to 10 days
Circulatory insufficiency	Need in medicamental vasopressor support more than 1 day	up to 10 days
Infection rate	Number of patients who develop systemic infection and/or operation wound infection	up to 10 days
Length of intensive care stay	Duration of summarized length in ICU, including readmission to ICU	up to 10 days

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Study Director: Boris Akselrod, Professor, Petrovsky NRCS

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 25, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm
• Other Study ID Numbers: 039420200002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No