The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The composite of in-hospital death of any cause
研究概览
简要总结
The aim of the present study is the evaluation of the occurrence and effect of hepatic dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in liver haemodynamics in the early postoperative period.
详细描述
Prospective, consecutive study of patients undergoing cardiac surgery in Heart and Vascular Center, Semmelweis University, Budapest.
Registered data:
- Anamnestic and demographic data
- Liver dysfunction prior surgery, etiology of liver dysfunction
- Perioperative clinical data: laboratory tests, imaging, haemodynamic measures
- risk prediction score of the American Society of Anesthesiologists(ASA), EUROpean System for Cardiac Operative Risk Evaluation (EuroScore), Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score (SAPS II), Canadian Cardiovascular Society grading of angina pectoris (CCS)
- Model for End-Stage Liver Disease (MELD), MELD excluding International Normalised Ratio (INR) (MELD-XI), modified MELD score (modMELD), Child-Pugh
The occurrence and etiology pattern of hepatic impairment are going to be evaluated according to age and type of cardiac illness. Correlations between perioperative haemodynamical alterations and structural, functional changes in hepatic status will be investigated.
The impact of hepatic impairment on surgical outcome is going to be examined by multivariate regression models.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age admitted for elective cardiac surgical procedures
排除标准
- •Not willing to participate.
- •Pregnant women.
- •During active psychiatric hospital care.
- •Patients with defined legal incapability or limited capability.
- •Non-evaluable patient due to insufficient clinical information
- •Patients with a transplanted heart.
结局指标
主要结局
The composite of in-hospital death of any cause
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ICU stay
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of hospital stay
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
次要结局
- Evidence of clinically definite postoperative decline in hepatic function(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Need for reoperation due to bleeding or cardiac cause(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Evidence of clinically definite postoperative low cardiac output syndrome(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Evidence of clinically definite postoperative acute kidney injury and the need for dialysis(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Evidence of clinically definite postoperative impaired coagulation(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Evidence of clinically definite postoperative pulmonary or systemic congestion(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
研究者
Andrea Szekely
associate professor
Semmelweis University