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Completed

NCT Number: NCT04548167

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.

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Key information

Conditions

Bloodstream Infection (BSI) Cross Infection Disease Attributes Iatrogenic Disease Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Herzchirurgie, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. Extracorporeal circulation time during surgery (minutes)

    Time frame: one time assessment at baseline

    Extracorporeal circulation time during surgery (minutes)

  3. 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

  4. 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

Secondary outcomes

  1. Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization

    Time frame: during hospital stay (usually up to 4 weeks)

    Incidence of cardiovascular events during hospitalization

  2. 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 events (stroke, myocardial infarction) during follow-up

  3. Incidence of cardiovascular re-operation during the follow up

    Time frame: after hospital discharge until follow- up assessment (up to 10 years)

    Incidence of cardiovascular re-operation during the follow up

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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