Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

Bloodstream Infection (BSI) Clinical Trial

Official title:

Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548167
• Other study ID #: 2020-00210; ch20Berdajs2
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: October 22, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7064
• Est. completion date: October 22, 2021
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bloodstream Infection (BSI)
• Communicable Diseases
• Cross Infection
• Infections
• Sepsis

Locations

Country	Name	City	State
Switzerland	Klinik für Herzchirurgie, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Extracorporeal circulation time during surgery (minutes)	Extracorporeal circulation time during surgery (minutes)	one time assessment at baseline
Primary	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)
Primary	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	Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization	Incidence of cardiovascular events during hospitalization	during hospital stay (usually up to 4 weeks)
Secondary	Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up	Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up	after hospital discharge until follow- up assessment (up to 10 years)
Secondary	Incidence of cardiovascular re-operation during the follow up	Incidence of cardiovascular re-operation during the follow up	after hospital discharge until follow- up assessment (up to 10 years)