postoperatieve complicaties complication complications after lung surgery postoperative outcome
Conditions
Interventions
None listed
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Elective pulmonary surgery (pneumonectomy, (bi)(sleeve)lobectomy, segmentectomy) for cancer, American Society of Anesthesiologists (ASA) physical status classification >=2 with a planned postoperative admission to the Intensive Care.
Exclusion criteria
Exclusion criteria: (suspected) Infection at the time of surgery and reoperation within 24 hours of surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are levels of IL-6, CRP, leucocyte count, PCT, ntproBNP, GDF-15 and hs-cTn. Primary endpoint is the development of an infectious complication which is defined as one of the following outcomes within 30 days of surgery: - pneumonia (purulent sputum, positive sputum or blood culture and clinical symptoms such as cough, fever or consolidation on chest radiograph) - pulmonary empyema (pleural effusion and the presence of pus on pleural aspiration, microorganism on pleural fluid culture or positive pleural fluid Gram stain) - sepsis (qSOFA score >=2 in response to an infection) - wound infection (purulent drainage from superficial incision or deliberate opening of superficial incision by surgeon and pain, tenderness, swelling or redness) - 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is the development of a non-infectious complication which is defined as one of the following outcomes within 30 days of surgery: - acute kidney injury (increase in serum creatinine by >= 26 µmol/l, a percentage increase in serum creatinine of more than or equal to 50% or oliguria of less than 0.5 ml/kg per hour for more than six hours within 48 hours) - respiratory insufficiency (hypoxia or hypercapnia leading to ICU (re)admission) - reoperation - supraventricular arrhythmia (new-onset atrial fibrillation or atrial flutter) - congestive heart failure (pleural effusion or pulmonary edema requiring diuretic therapy) - acute respiratory distress syndrome (defined as diffuse inflammatory lung injury (onset over 1 week or less), bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph, PF ratio = 75% in a pulmonary artery with corresponding normal ventilation - 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) - mortality Other secondary endpoints that will be captured are any complication (which is a composite of infectious and non-infectious complications within 30 days of surgery), length of ICU stay and length of hospital stay. For both the primary and secondary endpoints the exact time (in hours and days after surgery, and during or after ICU admission) on which the endpoint is reached will be noted. | — |
Countries
Netherlands
Outcome results
None listed