Gender Influence on Mortality and Major Morbidity After Pediatric Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Recent studies show an important influence of gender on inflammatory reactions. Cardiac surgery is associated with a major systemic inflammatory response. The investigators want to evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.
详细描述
Gender plays an important role in the inflammatory response. This is due to hormonal influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass, is associated with a major inflammatory response. This response is even more marked in pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on mortality and major morbidity in paediatric patients undergoing cardiac surgery. The investigators will do a retrospective cohort study, analysing the local database of all paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any difference in mortality and /or major morbidity according to gender.
Statistical analysis
The investigators will use a propensity score on 11 pre-operative variables clinically judged relevant. Both group will be matched until a absolute standardised difference < 15% is obtained. This type of matching, contrary to a P value, is independent of sample size. Variables will be presented as mean, standard deviation or percentage for frequency distributions. After propensity score matching, logistic regressions will be performed on binary variables and linear regressions on continuous variables. A Bonferroni correction will be used for multiple comparisons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass
排除标准
- •Jehova's witness
结局指标
主要结局
Mortality
时间窗: Beginning of the operation until 5 days postop
Mortality in paediatric cardiac surgery
Morbidity
时间窗: Beginning of the operation until 5 days postop
Major morbidity in paediatric cardiac surgery, defined as at least 2 of the following conditions: Respiratory failure (mechanical ventilation \> 90h), prolonged inotropic support (\> 5 mcg/kg/min of dobutamine for more than 48h postop), renal insufficiency (Drop in glomerular filtration rate \> 75% compared to preop values)
次要结局
未报告次要终点
研究者
Denis SCHMARTZ
Head, Department of Anesthesiology
Brugmann University Hospital