Aortic Aneurysm, Aortic Dissection, Complication, Thoracoabdominal Aneurysm
Conditions
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.
Detailed description
This study aims to assess the association between levels of biomarkers and postoperative complications in patients after thoracic and thoracoabdominal aortic reconstruction.
Interventions
DIAGNOSTIC_TESTblood sample tests for determination of biomarkers levels
Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.
Sponsors
Petrovsky National Research Centre of Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Elective thoracic and thoracoabdominal surgery
Exclusion criteria
* Hemolysis in blood sample
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Total Postoperative Complications | up to 10 days | Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number Affected by All-Cause Mortality | up to 10 days | Overall number of participants, in each arm/group, who died due to any cause |
| Number of Participants Who Require Extracorporeal Detoxication | up to 10 days | — |
| Number of Cardiac Disorders | up to 10 days | Number of patients who needed medicamental cardiotonic support more than 1 day |
| Number of Vascular Disorders | up to 10 days | Number of patients who needed vasopressor support more than 1 day |
| Number of Infections and Infestations | up to 10 days | Number of patients who develop systemic infection and/or operation wound infection |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thoracic Aorta Surgery Patients Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired
blood sample tests for determination of biomarkers levels: Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications. | 132 |
| Total | 132 |
Baseline characteristics
| Characteristic | Thoracic Aorta Surgery Patients |
|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 13 |
| Body surface area, м² | 2 square meters STANDARD_DEVIATION 0.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 132 Participants |
| Region of Enrollment Russia | 132 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 132 |
| other Total, other adverse events | 24 / 132 |
| serious Total, serious adverse events | 41 / 132 |
Outcome results
Primary
Number of Total Postoperative Complications
Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.
Time frame: up to 10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Aorta Surgery Patients | Number of Total Postoperative Complications | 69 post-operative complications |
Secondary
Number of Cardiac Disorders
Number of patients who needed medicamental cardiotonic support more than 1 day
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Aorta Surgery Patients | Number of Cardiac Disorders | 16 Participants |
Secondary
Number of Infections and Infestations
Number of patients who develop systemic infection and/or operation wound infection
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Aorta Surgery Patients | Number of Infections and Infestations | 36 Participants |
Secondary
Number of Participants Who Require Extracorporeal Detoxication
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Aorta Surgery Patients | Number of Participants Who Require Extracorporeal Detoxication | 7 Participants |
Secondary
Number of Vascular Disorders
Number of patients who needed vasopressor support more than 1 day
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Aorta Surgery Patients | Number of Vascular Disorders | 14 Participants |
Secondary
Total Number Affected by All-Cause Mortality
Overall number of participants, in each arm/group, who died due to any cause
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Aorta Surgery Patients | Total Number Affected by All-Cause Mortality | 2 Participants |