Bloodstream Infection (BSI) Clinical Trial
Official title:
Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection
| Verified date | November 2021 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Klinik für Herzchirurgie, University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| 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) |