Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer

Aarne Feldheiser30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Perioperative Early Tiredness (Acute Fatigue)Electrical Cardiometry Biosignals

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Acute Fatigue Score (AFS)

Rating of the AFS

Time frame: 1 hour after the end of anaesthesia

Secondary Outcomes

Acute Fatigue Score (AFS)

Perioperative time course of the ratings of AFS

Time frame: 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)

Inter-Rater Variability of Acute Fatigue Score (AFS)

The scores will be assessed by two observers and the variability determined

Time frame: 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)

Previously published score to measure tiredness

Time frame: 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 variables and catecholamine administration

Hemodynamic variables are assessed by the anesthesia monitor

Time frame: Up to the fifth postoperative day

Hemodynamic variables obtained by Electrical Cardiometry (EC)

EC is a method of bioimpedance

Time frame: 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)

Hemodynamic shock indices calculated from Electrical Cardiometry (EC)

EC is a method of bioimpedance

Time frame: 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)

Heart rate variability, cardiorespiratory coupling, pulse wave velocity and new markers calculated from raw biosignals

Bioelectrical signals to assess the interaction of the cardiac and pulmonary rhythms

Time frame: 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

Metabolomic, proteomic, immunological, endothelial and inflammatory markers obtained by intramuscular microdialysis

Time frame: Up to the first postoperative day

Mitochondrial respiratory chain activities

Respiratory chain activities are assessed in muscle biopsies using high-resolution respirometry

Time frame: Up to the first postoperative day

Nutrition associated antibodies and deficiency states of vitamins and trace elements

Biochemical parameters of nutrition states and immunological marker of alimentary components are determined

Time frame: Up to the fifth postoperative day

Blood loss

Perioperative blood loss characteristics

Time frame: Up to the fifth postoperative day

Body temperature

Body temperature will be assessed continuously and discontinuously

Time frame: Up to the first postoperative day

Fluid balances

The balances between all orally and intravenously administered fluids and all fluid losses

Time frame: 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 coagulation markers

Parameters characterizing the humoral and cellular (thrombocytes) coagulation will be determined

Time frame: Up to the fifth postoperative day

Immunologic, endothelial and hepatic markers

Parameters characterizing the time course of immunological (e.g. Interleukin-6) and endothelial (e.g. Intercellular Adhesion Molecule 1) and hepatic (e.g. cytokeratin-18) response will be determined

Time frame: Up to the fifth postoperative day

Organ dysfunctions and complications

Organ complications are classified according to Clavien-Dindo classification

Time frame: 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)

Microvascular function

Microvascular function is assessed by near-infrared spectroscopy (NIRS) combined with a vascular occlusion test (VOT)

Time frame: Up to the fifth postoperative day and at hospital discharge (an average of two weeks)

Functional status

Measured by the Barthel activities of daily living (ADL) index and activities of daily living (IADL)

Time frame: 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

Time from admission to discharge from the intensive care unit

Time frame: Participants will be followed up until intensive care unit discharge (an average of two days)

Hospital length of stay

Time from admission to discharge from the hospital

Time frame: Participants will be followed up until hospital discharge (expected average of 14 days)

Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes