Bloodstream Infection (BSI)NCT04548167
Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection
An observational study of Bloodstream Infection (BSI), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection (BSI)
- How many people
- 7,064 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 22 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having suffered from sepsis after cardiac surgery in a period between 2009 and 2019 will be evaluated.
Who may be able to join
- adult patients undergoing cardiac surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Herzchirurgie, University Hospital Basel
Basel, 4031
About this study
This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.
Read the 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.
- Conditions
- Bloodstream Infection (BSI)
- Keywords
- cardiovascular surgery, cardiopulmonary bypass (CPB), nosocomial infection, early bloodstream infection, postoperative septicaemia
- Medical subject headings
- Sepsis, Cross Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 7 days after a cardiovascular surgery
Extracorporeal circulation time during surgery (minutes)
Extracorporeal circulation time during surgery (minutes)
Measured: 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
Measured: 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
Measured: during hospital stay (usually up to 4 weeks)
Secondary outcomes (3)
Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization
Incidence of cardiovascular events during hospitalization
Measured: 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
Measured: 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
Measured: after hospital discharge until follow- up assessment (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Sep 2020
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream Infection (BSI)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Berdajs, Prof. Dr. med., Principal investigator, Klinik für Herzchirurgie, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548167
- Sponsor's protocol ID
- 2020-00210; ch20Berdajs2
- Status last verified
- Nov 2021
- First submitted
- 2 Sep 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection
- ClinicalTrials.gov ID
- NCT04548167
- Acronym / sponsor ID
- 2020-00210; ch20Berdajs2
- Conditions
- Bloodstream Infection (BSI)
- Keywords
- cardiovascular surgery, cardiopulmonary bypass (CPB), nosocomial infection, early bloodstream infection, postoperative septicaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,064 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having suffered from sepsis after cardiac surgery in a period between 2009 and 2019 will be evaluated.
Key inclusion criteria (1 listed)
- adult patients undergoing cardiac surgery
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
3 secondary outcomes
Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization
Time frame: during hospital stay (usually up to 4 weeks)
Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up
Time frame: after hospital discharge until follow- up assessment (up to 10 years)
Incidence of cardiovascular re-operation during the follow up
Time frame: after hospital discharge until follow- up assessment (up to 10 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Berdajs, Prof. Dr. med. principal investigator
Klinik für Herzchirurgie, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection (BSI), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.