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Clinical Trials/NCT04548167
NCT04548167
Completed
Not Applicable

Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

University Hospital, Basel, Switzerland1 site in 1 country7,064 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bloodstream Infection (BSI)
Sponsor
University Hospital, Basel, Switzerland
Enrollment
7064
Locations
1
Primary Endpoint
Extracorporeal circulation time during surgery (minutes)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
October 22, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Extracorporeal circulation time during surgery (minutes)

Time Frame: one time assessment at baseline

Extracorporeal circulation time during surgery (minutes)

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

Time Frame: during hospital stay (usually up to 4 weeks)

In-hospital mortality is defined as death before discharge

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

Time Frame: during hospital stay (usually up to 4 weeks)

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

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

Time Frame: within 7 days after a cardiovascular surgery

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

Secondary Outcomes

  • Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization(during hospital stay (usually up to 4 weeks))
  • Incidence of cardiovascular re-operation during the follow up(after hospital discharge until follow- up assessment (up to 10 years))
  • Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up(after hospital discharge until follow- up assessment (up to 10 years))

Study Sites (1)

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