Association of Perioperative Early Tiredness (Acute Fatigue) With Hemodynamic, Immunologic, Endothelial, Metabolic, Gastrointestinal Measures and Complications in Patients With Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute Fatigue Score (AFS)
研究概览
简要总结
In surgical patients early risk prediction of postoperative complications and organ dysfunctions is still an important clinical challenge whereas appropriate risk predictors are still missing. In this regard, fatigue is a complex phenomenon, is affected by many factors and has been shown to be associated with delayed return to normal activity after surgery. The investigators hypothesize that early tiredness (acute fatigue) assessed shortly after surgery is associated to postoperative complications and organ dysfunctions and might be used for risk stratification. Therefore, in this prospective, observational study the investigators introduce and evaluate a newly developed score to assess early fatigue during the perioperative period ("Acute Fatigue Score", AFS).
The AFS and the Identity-Consequence Fatigue Scala will be used to assess early fatigue and perioperative time courses and inter-rater-variability will be evaluated. The rating of these two fatigue scores will be evaluated regarding the association with hemodynamic, immunologic, endothelial, metabolic, gastrointestinal measures as well as organ dysfunction and complications after surgery.
Furthermore, hemodynamic, immunologic, endothelial, metabolic and gastrointestinal measures are investigated with respect to the intraoperative course and postoperative organ dysfunction and complications. In a subgroup of patients, patients will undergo specialized metabolic measures to investigate mitochondrial dysfunction during the perioperative period.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with epithelial ovarian cancer scheduled for cytoreductive surgery at the Department of Gynecology at Campus Virchow - Klinikum, Charité - University Berlin
- •Offered patient information and written informed consent
排除标准
- •Patients aged less than 18 years
- •Persons without the capacity to consent
- •Inability of German language use
- •Lacking willingness to save and hand out data within the study
- •Accommodation in an institution due to an official or judicial order
- •(Unclear) history of alcohol or substances disabuse
- •Coworker of the Charité
- •Known Myopathy
- •Neurological or psychiatric disease at the beginning of hospitalization
- •CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalization
- •American Society of Anesthesiologists (ASA) classification greater than IV
- •Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization
- •Pulmonary oedema in thorax x-ray at the beginning of hospitalization
- •History of intracranial hemorrhage within one year before participation in the study
- •Conditions following venous thrombosis within the last three years before study inclusion
- •Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions
- •Diabetes mellitus with signs of severe neuropathy
- •Known atrial fibrillation
- •Participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.
结局指标
主要结局
Acute Fatigue Score (AFS)
时间窗: 1 hour after the end of anaesthesia
Rating of the AFS
次要结局
- Hemodynamic variables and catecholamine administration(Up to the fifth postoperative day)
- Body temperature(Up to the first postoperative day)
- Immunologic, endothelial and hepatic markers(Up to the fifth postoperative day)
- Acute Fatigue Score (AFS)(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before and after the first cycle of chemotherapy (an average of four to six weeks))
- Identity-Consequence Fatigue Scala (ICFS)(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before and after the first cycle of chemotherapy (an average of four to six weeks))
- Fluid balances(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks))
- Organ dysfunctions and complications(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks))
- Functional status(At baseline, hospital discharge (expected average of 14 days) and before and after the first cycle of chemotherapy (an average of four to six weeks))
- Intensive care unit length of stay(Participants will be followed up until intensive care unit discharge (an average of two days))
- Inter-Rater Variability of Acute Fatigue Score (AFS)(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before and after the first cycle of chemotherapy (an average of four to six weeks))
- Hemodynamic shock indices calculated from Electrical Cardiometry (EC)(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks))
- Metabolomics/Proteomics(Up to the first postoperative day)
- Mitochondrial respiratory chain activities(Up to the first postoperative day)
- Blood coagulation markers(Up to the fifth postoperative day)
- Hemodynamic variables obtained by Electrical Cardiometry (EC)(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks))
- Blood loss(Up to the fifth postoperative day)
- Hospital length of stay(Participants will be followed up until hospital discharge (expected average of 14 days))
- Heart rate variability, cardiorespiratory coupling, pulse wave velocity and new markers calculated from raw biosignals(Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks))
- Nutrition associated antibodies and deficiency states of vitamins and trace elements(Up to the fifth postoperative day)
- Microvascular function(Up to the fifth postoperative day and at hospital discharge (an average of two weeks))
研究者
Aarne Feldheiser
Consultant
Charite University, Berlin, Germany