Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

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 Overview

• Status: Completed
• Conditions: Bloodstream Infection (BSI)

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 Type: Observational
• Enrollment (Actual): 7064

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Klinik für Herzchirurgie, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization	Incidence of cardiovascular events during hospitalization	during hospital stay (usually up to 4 weeks)
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Denis Berdajs, Prof. Dr. med., Klinik für Herzchirurgie, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ACTUAL): October 22, 2021
• Study Completion (ACTUAL): October 22, 2021

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: cardiovascular surgery; nosocomial infection; cardiopulmonary bypass (CPB); early bloodstream infection; postoperative septicaemia
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Iatrogenic Disease; Sepsis; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: 2020-00210; ch20Berdajs2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No