Clinical trial NCT04548167: Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection
Official title: Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bloodstream Infection (BSI)
Keywords: cardiovascular surgery
cardiopulmonary bypass (CPB)
nosocomial infection
early bloodstream infection
postoperative septicaemia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 7064
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having suffered from sepsis after cardiac surgery in a period between 2009 and 2019 will be evaluated.

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.

Detailed description: Infectious complications after cardiovascular surgery, especially in operations that use cardiopulmonary bypass (CPB), is associated with significant morbidity and increase in peri-operative mortality. Prolonged CPB usage could be predictive for early bloodstream infection following cardia surgery. This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing cardiac surgery

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of bloodstream infection (BSI) in postoperative period (clinical evidence of sepsis with laboratory-confirmed bacteraemia from blood sample)
timeFrame: within 7 days after a cardiovascular surgery
measure: Extracorporeal circulation time during surgery (minutes)
timeFrame: one time assessment at baseline
measure: In-hospital mortality (number) for patients with BSI vs those without BSI after a cardiovascular surgery
timeFrame: during hospital stay (usually up to 4 weeks)
measure: Surgical intervention rate (Incidence of cardiovascular re-operation) during the initial hospital stay (number)
timeFrame: during hospital stay (usually up to 4 weeks)
Secondary outcomes:
measure: Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization
timeFrame: during hospital stay (usually up to 4 weeks)
measure: Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up
timeFrame: after hospital discharge until follow- up assessment (up to 10 years)
measure: Incidence of cardiovascular re-operation during the follow up
timeFrame: after hospital discharge until follow- up assessment (up to 10 years)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Herzchirurgie, University Hospital Basel
Study officials:
affiliation: Klinik für Herzchirurgie, University Hospital Basel
name: Denis Berdajs, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: