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Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

NCT ID: NCT06336213

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2025-12-15

Brief Summary

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According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis.

Detailed Description

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Various biomarkers are being used to improve the quality of prediction models aiming to improve clinical outcomes and reduce mortality in the cardiac surgery patient population. In particular, presepsin and procalcitonin have comparable prognostic value for adverse renal, cardiovascular and respiratory outcomes in cardiac surgery patients. In addition, presepsin has in-hospital, 30-day, and 6-month prognostic mortality rate value and is also highly effective for the early diagnosis of sepsis in patients in the intensive care unit. In the previous study the absence of an increase in the level of presepsin in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period (OR 4.15, 95% CI: 1.83-9.41). The combination of two risk factors - a presepsin level at the end of surgery \>519.5 pg/ml and the absence of an increase in the presepsin level in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period (OR 5.80, 95% CI: 2. 19-15.35). The hypothesis of this study suggests that in case of insufficient prevention of infectious complications, based on the dynamics of presepsin, it is permissible to administer the broad-spectrum drug ampicillin/sulbactam 3 g. every 6 hours for at least 72 hours from the date of surgery. It is expected that changes in the tactics of antibacterial therapy will reduce the number of inflammatory complications in patients undergoing surgery on thoracic aorta.

Conditions

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Aortic Aneurysm and Dissection Cardiac Valve Disease Thoracic Aortic Aneurysm Thoracic Aortic Dissection

Keywords

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biomarkers presepsin complications aortic arch aorta aortic aneurysm ascending aorta cardiac surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ampicillin/sulbactam intervention group

If a patient meets dual criteria (presepsin \> 519,5 pg/ml at the end of surgery and the absence of presepsin increase after 6 hours after the end of surgery) then switching to ampicillin/sulbactam 3 g every 6 hours at least 72 h after the surgery is done.

Group Type EXPERIMENTAL

Ampicillin-sulbactam

Intervention Type DRUG

If a patient meets dual criteria (presepsin \> 519,5 pg/ml at the end of surgery and the absence of presepsin increase after 6 hours after the end of surgery) then switching to ampicillin/sulbactam 3 g every 6 hours at least 72 h after the surgery is done.

Cefazolin

If presepsin \< 519,5 pg/ml at the end of surgery, cefazolin 2 g every 6 h at least 72 h p/o is continued further

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ampicillin-sulbactam

If a patient meets dual criteria (presepsin \> 519,5 pg/ml at the end of surgery and the absence of presepsin increase after 6 hours after the end of surgery) then switching to ampicillin/sulbactam 3 g every 6 hours at least 72 h after the surgery is done.

Intervention Type DRUG

Other Intervention Names

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sulmacefta, amibactam

Eligibility Criteria

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Inclusion Criteria

Thoracic aorta aneurysm/dissection

Exclusion Criteria

Blood sample hemolysis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris Akselrod, Professor

Role: PRINCIPAL_INVESTIGATOR

Petrovsky NRCS

Locations

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Petrovsky Research National Centre of Surgery (Petrovsky NRCS)

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Artem Gubko, Ph.D.

Role: CONTACT

Phone: +79684241490

Email: [email protected]

Boris Akselrod, Professor

Role: CONTACT

Phone: +79257403797

Email: [email protected]

Facility Contacts

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Artem Gubko, Ph.D.

Role: primary

Other Identifiers

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20240306

Identifier Type: -

Identifier Source: org_study_id