Clinical trial NCT03131102: Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer
Official title: Association of Perioperative Early Tiredness (Acute Fatigue) With Hemodynamic, Immunologic, Endothelial, Metabolic, Gastrointestinal Measures and Complications in Patients With Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Early Tiredness (Acute Fatigue)
Electrical Cardiometry
Biosignals
Mitochondrial Dysfunction
Nutrition
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Experimental & Clinical Research Center Berlin
name: German Institute of Human Nutrition
name: Humboldt-Universität zu Berlin
name: Technische Universität Berlin
First posted: 2017-04-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epithelial ovarian cancer undergoing cytoreductive surgery

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute Fatigue Score (AFS)
timeFrame: 1 hour after the end of anaesthesia
Secondary outcomes:
measure: Acute Fatigue Score (AFS)
timeFrame: 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)
measure: Inter-Rater Variability of Acute Fatigue Score (AFS)
timeFrame: 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)
measure: Identity-Consequence Fatigue Scala (ICFS)
timeFrame: 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)
measure: Hemodynamic variables and catecholamine administration
timeFrame: Up to the fifth postoperative day
measure: Hemodynamic variables obtained by Electrical Cardiometry (EC)
timeFrame: 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)
measure: Hemodynamic shock indices calculated from Electrical Cardiometry (EC)
timeFrame: 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)
measure: Heart rate variability, cardiorespiratory coupling, pulse wave velocity and new markers calculated from raw biosignals
timeFrame: 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)
measure: Metabolomics/Proteomics
timeFrame: Up to the first postoperative day
measure: Mitochondrial respiratory chain activities
timeFrame: Up to the first postoperative day
measure: Nutrition associated antibodies and deficiency states of vitamins and trace elements
timeFrame: Up to the fifth postoperative day
measure: Blood loss
timeFrame: Up to the fifth postoperative day
measure: Body temperature
timeFrame: Up to the first postoperative day
measure: Fluid balances
timeFrame: 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)
measure: Blood coagulation markers
timeFrame: Up to the fifth postoperative day
measure: Immunologic, endothelial and hepatic markers
timeFrame: Up to the fifth postoperative day
measure: Organ dysfunctions and complications
timeFrame: 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)
measure: Microvascular function
timeFrame: Up to the fifth postoperative day and at hospital discharge (an average of two weeks)
measure: Functional status
timeFrame: 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)
measure: Intensive care unit length of stay
timeFrame: Participants will be followed up until intensive care unit discharge (an average of two days)
measure: Hospital length of stay
timeFrame: Participants will be followed up until hospital discharge (expected average of 14 days)
Other outcomes:
measure: Quality of life
timeFrame: At baseline, hospital discharge (expected average of 14 days)
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - University Medicine Berlin
name: Oliver Hunsicker, MD
role: PRINCIPAL_INVESTIGATOR
References: