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

Association of Perioperative Early Tiredness (Acute Fatigue) With Hemodynamic, Immunologic, Endothelial, Metabolic, Gastrointestinal Measures and Complications 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.

Study Overview

• Status: Completed
• Conditions: Nutrition; Mitochondrial Dysfunction; Electrical Cardiometry; Perioperative Early Tiredness (Acute Fatigue); Biosignals

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with epithelial ovarian cancer undergoing cytoreductive surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients with epithelial ovarian cancer (EOC); Patients undergoing cytoreductive surgery due to epithelial ovarian cancer
Subgroup - Metabolomics in EOC patients without ascites; In a subgroup (n=10), patients without preoperative ascites will undergo extended metabolic measures to investigate mitochondrial dysfunction during the preoperative period.
Subgroup - Metabolomics in EOC patients with ascites >500ml; In a subgroup (n=10), patients with preoperative ascites >500ml will undergo extended metabolic measures to investigate mitochondrial dysfunction during the preoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Fatigue Score (AFS)	Rating of the AFS	1 hour after the end of anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Fatigue Score (AFS)	Perioperative time course of the ratings of 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)
Inter-Rater Variability of Acute Fatigue Score (AFS)	The scores will be assessed by two observers and the variability determined	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	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	Up to the fifth postoperative day
Hemodynamic variables obtained by Electrical Cardiometry (EC)	EC is a method of bioimpedance	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	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	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	Up to the first postoperative day
Mitochondrial respiratory chain activities	Respiratory chain activities are assessed in muscle biopsies using high-resolution respirometry	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	Up to the fifth postoperative day
Blood loss	Perioperative blood loss characteristics	Up to the fifth postoperative day
Body temperature	Body temperature will be assessed continuously and discontinuously	Up to the first postoperative day
Fluid balances	The balances between all orally and intravenously administered fluids and all fluid losses	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	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	Up to the fifth postoperative day
Organ dysfunctions and complications	Organ complications are classified according to Clavien-Dindo classification	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)	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)	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	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	Participants will be followed up until hospital discharge (expected average of 14 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Assessed with EQ-5D questionnaire by the EuroQol Group	At baseline, hospital discharge (expected average of 14 days)

Collaborators and Investigators

• Sponsor: Aarne Feldheiser
• Collaborators: Technische Universität Berlin; Humboldt-Universität zu Berlin; German Institute of Human Nutrition; Experimental & Clinical Research Center Berlin
• Investigators: Principal Investigator: Oliver Hunsicker, MD, Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - University Medicine Berlin

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): October 9, 2018
• Study Completion (Actual): October 9, 2018

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Fatigue; Mitochondrial Diseases; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: PERISCOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No