complications iron status
Conditions
Interventions
None listed
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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: Emergent or urgent surgery Acute infection Haemochromatosis Illiteracy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are perioperative levels of haemoglobin, mean corpuscular volume (MCV), reticulocyte count, reticulocyte haemoglobin content, red blood cell count, red cell distribution width (RDW), ferritin, transferrin, transferrin saturation (TSAT), serum iron, vitamin B12, folate, C-reactive protein (CRP), creatinine, eGFR. Anaemia and iron status are defined as: - Anaemia: haemoglobin level 5 mg/l) OR reticulocyte haemoglobin count 100 µg/l, TSAT 5 mg/l Low levels of erytroid maturation factors are defined as vitamin B12 level | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 a 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 calender 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 | — |
Countries
Netherlands
Outcome results
None listed