Trial Outcomes & Findings for Biomarkers in Thoracic Aorta Surgery (NCT NCT04689139)

NCT ID: NCT04689139

Last Updated: 2024-09-19

Results Overview

Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 132 participants
• Primary outcome timeframe: up to 10 days
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	132
Overall Study COMPLETED	132
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biomarkers in Thoracic Aorta Surgery

Baseline characteristics by cohort

Measure	Thoracic Aorta Surgery Patients n=132 Participants 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.
Age, Continuous	56 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Russia	132 Participants n=5 Participants
Body surface area, м²	2 square meters STANDARD_DEVIATION 0.22 • n=5 Participants

PRIMARY outcome

Timeframe: up to 10 days

Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.

Outcome measures

Measure	Thoracic Aorta Surgery Patients n=132 Participants 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.
Number of Total Postoperative Complications	69 post-operative complications

SECONDARY outcome

Timeframe: up to 10 days

Overall number of participants, in each arm/group, who died due to any cause

Outcome measures

Measure	Thoracic Aorta Surgery Patients n=132 Participants 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.
Total Number Affected by All-Cause Mortality	2 Participants

SECONDARY outcome

Timeframe: up to 10 days

Outcome measures

Measure	Thoracic Aorta Surgery Patients n=132 Participants 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.
Number of Participants Who Require Extracorporeal Detoxication	7 Participants

SECONDARY outcome

Timeframe: up to 10 days

Number of patients who needed medicamental cardiotonic support more than 1 day

Outcome measures

Measure	Thoracic Aorta Surgery Patients n=132 Participants 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.
Number of Cardiac Disorders	16 Participants

SECONDARY outcome

Timeframe: up to 10 days

Number of patients who needed vasopressor support more than 1 day

Outcome measures

Measure	Thoracic Aorta Surgery Patients n=132 Participants 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.
Number of Vascular Disorders	14 Participants

SECONDARY outcome

Timeframe: up to 10 days

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

Outcome measures

Measure	Thoracic Aorta Surgery Patients n=132 Participants 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.
Number of Infections and Infestations	36 Participants

Adverse Events

Thoracic Aorta Surgery Patients

Serious events: 41 serious events

Other events: 24 other events

Deaths: 2 deaths

Serious adverse events

Measure	Thoracic Aorta Surgery Patients n=132 participants at risk 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.
Renal and urinary disorders Patients requiring extracorporeal detoxication	5.3% 7/132 • Number of events 7 • Up to 10 days postoperative
Infections and infestations Pneumonia	22.0% 29/132 • Number of events 29 • Up to 10 days postoperative
Cardiac disorders Myocardial infarction	3.8% 5/132 • Number of events 5 • Up to 10 days postoperative

Other adverse events

Measure	Thoracic Aorta Surgery Patients n=132 participants at risk 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.
Cardiac disorders Cardiac dysrhythmias	18.2% 24/132 • Number of events 24 • Up to 10 days postoperative

Additional Information

Dr. Artem Gubko

Petrovsky NRCS

Phone: +79684241490

Email: gubko@artvig.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place