Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

NCT06336213 | Recruiting

• 1 other identifier: 20240306
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Infectious complications rate

  Postoperative pneumonia, sepsis, wound infection, mediastinitis

  up to 10 days

Secondary Outcomes (5)

• Total amount of complicated patients

  up to 10 days

• Mortality

  up to 10 days

• Length of hospital stay

  up to 10 days

• Length of ICU stay

  up to 10 days

• Multiorgan failure

  up to 10 days

Study Arms (2)

Ampicillin/sulbactam intervention group

EXPERIMENTAL

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.

Drug: Ampicillin-sulbactam

Cefazolin

NO INTERVENTION

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

Interventions

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.

Also known as: sulmacefta, amibactam

Ampicillin/sulbactam intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thoracic aorta aneurysm/dissection

You may not qualify if:

• Blood sample hemolysis

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Petrovsky Research National Centre of Surgery (Petrovsky NRCS)

Moscow, Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Heart Valve Diseases; Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta; Aortic Aneurysm

Interventions

sultamicillin

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Heart Diseases

Study Officials

• Boris Akselrod, Professor

  Petrovsky NRCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Artem Gubko, Ph.D.

CONTACT

+79684241490; gubko@artvig.ru

Boris Akselrod, Professor

CONTACT

+79257403797; aksel@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 28, 2024
• Study Start: January 23, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)