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

NCT03131102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-04-26

No results posted yet for this study

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

Sponsors & Collaborators

  • Experimental & Clinical Research Center Berlin

    collaborator UNKNOWN

  • German Institute of Human Nutrition

    collaborator OTHER

  • Humboldt-Universität zu Berlin

    collaborator OTHER

  • Technische Universität Berlin

    collaborator OTHER

  • Aarne Feldheiser

    lead OTHER

Principal Investigators

  • Oliver Hunsicker, MD · Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - University Medicine Berlin

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2018-10-09
Completion
2018-10-09

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131102 on ClinicalTrials.gov