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NCT Number: NCT06336213

Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Petrovsky Research National Centre of Surgery (Petrovsky NRCS)

Moscow, 119991, Russia

Location status: Recruiting

Location contact

Artem Gubko, Ph.D.

CONTACT

[email protected]

+79684241490

Boris Akselrod, Ph.D

PRINCIPAL_INVESTIGATOR

Denis Guskov, Ph.D

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Thoracic aorta aneurysm/dissection

Exclusion criteria

Blood sample hemolysis

Treatment and study plan

Ampicillin-sulbactam

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.

Other names: sulmacefta, amibactam

Primary outcomes

  1. Infectious complications rate

    Time frame: up to 10 days

    Postoperative pneumonia, sepsis, wound infection, mediastinitis

Secondary outcomes

  1. Total amount of complicated patients

    Time frame: up to 10 days

    Patients that suffer at least 1 complication in postoperative period

  2. Mortality

    Time frame: up to 10 days

    In-hospital mortality rate

  3. Length of hospital stay

    Time frame: up to 10 days

    Days spent in hospital since admission

  4. Length of ICU stay

    Time frame: up to 10 days

    Hours in ICU after the surgery

  5. Multiorgan failure

    Time frame: up to 10 days

    2 or more organ dysfunction in postoperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Artem Gubko, Ph.D.

CONTACT

[email protected]

+79684241490

Boris Akselrod, Professor

CONTACT

[email protected]

+79257403797

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Registry information

Official study title

Changes in Antibacterial Therapy Based on Perioperative Dynamics of Presepsin During Reconstructive Thoracic Aorta Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 28, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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