Iron status and outcome in cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27402

Enrollment

400

Registered

2019-07-12

Start date

2019-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abnormal iron status, cardiac surgery

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Elective cardiac surgery (CABG, aortic valve replacement, mitral valve replacement, aortic surgery, Maze, or combined surgery) - On-pump surgery - Age = 60 years

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Emergent or urgent surgery - Acute infection (e.g. endocarditis) - Haemochromatosis - Illiteracy

Design outcomes

Primary

Measure	Time frame
30-day packed red blood cell transfusion-free survival	—

Secondary

Measure	Time frame
o 30-day adverse event-free survival. Adverse events are (one of the following): - postoperative infection ? pneumonia (purulent sputum, positive sputum or blood culture and clinical symptoms, e.g. cough, fever or consolidation on chest radiograph) ? sepsis (qSOFA score =2 in response to an infection: one point for any of the following, glascow coma scale 21, systolic blood pressure 38°C), and purulent drainage from the mediastinum) ? urinary tract infection (urinary tract symptoms or fever and urine culture with no more than 2 species of organisms identified with at least one of which is a bacterium of =105 CFU/ml) ? central line associated bloodstream infection (laboratory confirmed bloodstream infection in a patient where the central line was in place for > 2 calendar days on the day of the event AND one of the following criteria: 1. patient has a recognized pathogen cultured from one or more blood cultures AND pathogen cultured is not related to an infection at another site 2. At least one of the following signs fever, chills, hypotension AND organism cultured from blood is not related to an infection at another site AND the same matching organism is cultured from two or more blood cultures on separate occasions) ? Other - acute kidney injury (increase in serum creatinine of = 26 µmol/l within 48 hours of surgery or an increase in serum creatinine tot 150% or more within 7 days or urine volume < 0.5ml/kg/h for 6 hours within 7 days) - renal replacement therapy within 7 days - stroke (clinical diagnosis of acute transient ischemic attack (TIA) or cerebrovascular accident (CVA)) - myocardial infarction (elevated hs-cTn in combination with clinical symptoms or electrocardiography changes) - 30-day mortality (+time) o Change in disability (measured with the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12-item version), which is defined as the difference between the score at 120 days after surgery and before s	—

Measure

Time frame

o 30-day adverse event-free survival. Adverse events are (one of the following): - postoperative infection ? pneumonia (purulent sputum, positive sputum or blood culture and clinical symptoms, e.g. cough, fever or consolidation on chest radiograph) ? sepsis (qSOFA score =2 in response to an infection: one point for any of the following, glascow coma scale 21, systolic blood pressure 38°C), and purulent drainage from the mediastinum) ? urinary tract infection (urinary tract symptoms or fever and urine culture with no more than 2 species of organisms identified with at least one of which is a bacterium of =105 CFU/ml) ? central line associated bloodstream infection (laboratory confirmed bloodstream infection in a patient where the central line was in place for > 2 calendar days on the day of the event AND one of the following criteria: 1. patient has a recognized pathogen cultured from one or more blood cultures AND pathogen cultured is not related to an infection at another site 2. At least one of the following signs fever, chills, hypotension AND organism cultured from blood is not related to an infection at another site AND the same matching organism is cultured from two or more blood cultures on separate occasions) ? Other - acute kidney injury (increase in serum creatinine of = 26 µmol/l within 48 hours of surgery or an increase in serum creatinine tot 150% or more within 7 days or urine volume < 0.5ml/kg/h for 6 hours within 7 days) - renal replacement therapy within 7 days - stroke (clinical diagnosis of acute transient ischemic attack (TIA) or cerebrovascular accident (CVA)) - myocardial infarction (elevated hs-cTn in combination with clinical symptoms or electrocardiography changes) - 30-day mortality (+time) o Change in disability (measured with the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12-item version), which is defined as the difference between the score at 120 days after surgery and before s

—

Contacts

Public ContactThijs Rettig

Amphia Hospital

trettig@amphia.nl0765955637

Outcome results