Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

Completed

• Conditions: Bloodstream Infection (BSI)

• Registration Number: NCT04548167
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-14
• Primary Completion: 2021-10-22
• Study Completion: 2021-10-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7064

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extracorporeal circulation time during surgery (minutes)	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	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)	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)	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 Outcome Measures

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

Trial Locations

Locations (1)

Klinik für Herzchirurgie, University Hospital Basel; 🇨🇭 Basel, Switzerland