ABSTRACT
BACKGROUND: High-dose corticosteroids have been used to attenuate the inflammatory response to cardiac surgery and cardiopulmonary bypass, but patient outcome benefits remain unclear. Our primary aim was to determine whether using dexamethasone was superior to not using dexamethasone to increase the number of home days in the first 30 days after cardiac surgery. Our secondary aim was to evaluate efficiency, value and impact of the novel trial design. METHODS: This pragmatic, international trial incorporating a prerandomized consent design favoring local practice enrolled patients undergoing cardiac surgery across 7 hospitals in Australia and The Netherlands. Patients were randomly assigned to dexamethasone, 1 mg/kg, or not (control). The primary outcome was the number of days alive and at home up to 30 days after surgery ("home days"). Secondary outcomes included prolonged mechanical ventilation (>48 h), sepsis, renal failure, myocardial infarction, stroke and death. RESULTS: Of 2093 patients assessed for eligibility, 1951 were randomized (median age 63 years, 80% male). The median number of home days was 23.0 (IQR, 20.1 to 24.1) in the dexamethasone group and 23.1 (IQR, 20.1 to 24.6) in the no dexamethasone group; median difference 0.1 (95% CI, -0.3 to 0.5), P=0.66. The rates of prolonged mechanical ventilation, RR 0.72 (95% CI, 0.48 to 1.08), sepsis, RR 1.02 (95% CI, 0.57 to 1.82), renal failure, RR 0.94 (95% CI, 0.80 to 1.12), myocardial infarction, RR 1.20 (95% CI, 0.30 to 4.82), stroke, RR 1.06 (95% CI, 0.54 to 2.08), and death, RR 0.72 (95% CI, 0.22 to 2.35), were comparable between groups (all P>0.10). Dexamethasone reduced intensive care unit stay, median 29 (IQR, 22 to 50) h vs. 43 (24 to 72) h, P=0.004. Our novel trial design was highly efficient (89.3% enrolment). CONCLUSIONS: Among patients undergoing cardiac surgery, high-dose dexamethasone decreased intensive care unit stay but did not increase the number of home days after surgery.
ABSTRACT
BACKGROUND: The aim of this study was to estimate the association between aortic cross clamp time and postoperative morbidity and mortality in patients undergoing mitral valve repair. METHODS: A retrospective cohort study between 2006 and 2014 was performed as a single Center study in the University Medical Center Utrecht. In total 1007 patients who underwent mitral valve repair were included. The patients were divided into a group who underwent isolated mitral valve repair and a group who underwent mitral valve repair with concomitant intervention(s). The primary endpoint was a composite consisting of in-hospital mortality or postoperative major complications. RESULTS: In the isolated mitral valve group (N.=405), patients were significantly younger, healthier and had fewer complications (9.9%). Patients with concomitant intervention(s) had a twofold higher rate of postoperative complications and mortality (18.1%). After adjustment for confounding there was no association between aortic cross clamp time and the primary endpoint in both the isolated mitral valve group (odds ratio 1.04; 95% CI: 0.98-1.11) and the group with concomitant interventions (odds ratio 1.02; 95% CI: 0.97-1.06). CONCLUSIONS: In patients undergoing mitral valve repair surgery a longer aortic cross clamp time was not associated with postoperative complications and mortality. The higher postoperative morbidity and mortality in combined procedures appears to be due to a higher age, more comorbidities and an extra intervention rather than to the duration of aortic cross clamp time.
