Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

NCT04548167 | Completed

• 1 other identifier: 2020-00210; ch20Berdajs2
• Study Type: observational
• Target: 7,064
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.

Conditions

Bloodstream Infection (BSI)

Keywords

cardiovascular surgery; cardiopulmonary bypass (CPB); nosocomial infection; early bloodstream infection; postoperative septicaemia

Outcome Measures

Primary Outcomes (4)

• Incidence of bloodstream infection (BSI) in postoperative period (clinical evidence of sepsis with laboratory-confirmed bacteraemia from blood sample)

  Incidence of bloodstream infection (BSI) in postoperative period (clinical evidence of sepsis with laboratory-confirmed bacteraemia from blood sample)

  within 7 days after a cardiovascular surgery

• Extracorporeal circulation time during surgery (minutes)

  Extracorporeal circulation time during surgery (minutes)

  one time assessment at baseline

• In-hospital mortality (number) for patients with BSI vs those without BSI after a cardiovascular surgery

  In-hospital mortality is defined as death before discharge

  during hospital stay (usually up to 4 weeks)

• Surgical intervention rate (Incidence of cardiovascular re-operation) during the initial hospital stay (number)

  Surgical intervention rate (Incidence of cardiovascular re-operation) during the initial hospital stay

  during hospital stay (usually up to 4 weeks)

Secondary Outcomes (3)

• Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization

  during hospital stay (usually up to 4 weeks)

• Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up

  after hospital discharge until follow- up assessment (up to 10 years)

• Incidence of cardiovascular re-operation during the follow up

  after hospital discharge until follow- up assessment (up to 10 years)

Eligibility Criteria

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

Study Population

Patients having suffered from sepsis after cardiac surgery in a period between 2009 and 2019 will be evaluated.

You may qualify if:

• adult patients undergoing cardiac surgery

You may not qualify if:

• patients having active or previous endocarditis
• patients whose causative microorganism of postoperative BSI was identical to that isolated from preoperative or intraoperative samples
• patients with common skin colonized microorganisms, such as coagulase-negative Staphylococci, Viridans group Streptococci, Corynebacterium species, Bacillus species, Propionibacterium species, and Aerococcus species or Micrococcus species, which were isolated from only a single blood sample and without evidence of clinical sepsis, because contamination was considered.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Klinik für Herzchirurgie, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Sepsis; Cross Infection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes

Study Officials

• Denis Berdajs, Prof. Dr. med.

  Klinik für Herzchirurgie, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 14, 2020
• Study Start: September 1, 2020
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Locations

CH (1)