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

NCT03131102 | Completed

• 1 other identifier: PERISCOPE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Early Tiredness (Acute Fatigue); Electrical Cardiometry; Biosignals; Mitochondrial Dysfunction; Nutrition

Outcome Measures

Primary Outcomes (1)

• Acute Fatigue Score (AFS)

  Rating of the AFS

  1 hour after the end of anaesthesia

Secondary Outcomes (20)

• 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)

• 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)

• 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)

• Hemodynamic variables and catecholamine administration

  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)

Other Outcomes (1)

• Quality of life

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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with epithelial ovarian cancer undergoing cytoreductive surgery

You may qualify if:

• 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

You may not qualify if:

• 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
• Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions

Sponsors & Collaborators

• Aarne Feldheiser: lead
• Experimental & Clinical Research Center Berlin: collaborator
• German Institute of Human Nutrition: collaborator
• Humboldt-Universität zu Berlin: collaborator
• Technische Universität Berlin: collaborator

Study Sites (1)

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

Berlin, 13353, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Muscle biopsies

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Oliver Hunsicker, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 27, 2017
• Study Start: August 29, 2017
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)