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Completed

NCT Number: NCT03131102

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

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.

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Key information

Conditions

Perioperative Early Tiredness (Acute Fatigue) Biosignals Electrical Cardiometry Metabolic Diseases Mitochondrial Diseases Mitochondrial Dysfunction Nutrition Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Acute Fatigue Score (AFS)

    Time frame: 1 hour after the end of anaesthesia

    Rating of the AFS

Secondary outcomes

  1. Acute Fatigue Score (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)

    Perioperative time course of the ratings of AFS

  2. Inter-Rater Variability of Acute Fatigue Score (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)

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

  3. Identity-Consequence Fatigue Scala (ICFS)

    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)

    Previously published score to measure tiredness

  4. Hemodynamic variables and catecholamine administration

    Time frame: Up to the fifth postoperative day

    Hemodynamic variables are assessed by the anesthesia monitor

  5. Hemodynamic variables obtained by Electrical Cardiometry (EC)

    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)

    EC is a method of bioimpedance

  6. Hemodynamic shock indices calculated from Electrical Cardiometry (EC)

    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)

    EC is a method of bioimpedance

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

    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)

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

  8. Metabolomics/Proteomics

    Time frame: Up to the first postoperative day

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

  9. Mitochondrial respiratory chain activities

    Time frame: Up to the first postoperative day

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

  10. Nutrition associated antibodies and deficiency states of vitamins and trace elements

    Time frame: Up to the fifth postoperative day

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

  11. Blood loss

    Time frame: Up to the fifth postoperative day

    Perioperative blood loss characteristics

  12. Body temperature

    Time frame: Up to the first postoperative day

    Body temperature will be assessed continuously and discontinuously

  13. Fluid balances

    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)

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

  14. Blood coagulation markers

    Time frame: Up to the fifth postoperative day

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

  15. Immunologic, endothelial and hepatic markers

    Time frame: Up to the fifth postoperative day

    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

  16. Organ dysfunctions and complications

    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)

    Organ complications are classified according to Clavien-Dindo classification

  17. Microvascular function

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

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

  18. Functional status

    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)

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

  19. Intensive care unit length of stay

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

    Time from admission to discharge from the intensive care unit

  20. Hospital length of stay

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

    Time from admission to discharge from the hospital

Other outcomes

  1. Quality of life

    Time frame: At baseline, hospital discharge (expected average of 14 days)

    Assessed with EQ-5D questionnaire by the EuroQol Group

Sponsors and collaborators

Lead sponsor

Aarne Feldheiser

Other

Collaborators

  • Experimental & Clinical Research Center Berlin
  • German Institute of Human Nutrition
  • Humboldt-Universität zu Berlin
  • Technische Universität Berlin

Registry information

Official study title

Association of Perioperative Early Tiredness (Acute Fatigue) With Hemodynamic, Immunologic, Endothelial, Metabolic, Gastrointestinal Measures and Complications in Patients With Epithelial Ovarian Cancer

Acronym: PERISCOPE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2017
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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