Perioperative Early Tiredness (Acute Fatigue)PERISCOPENCT03131102
Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer
An observational study of Perioperative Early Tiredness (Acute Fatigue) and Electrical Cardiometry, run by Aarne Feldheiser at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perioperative Early Tiredness (Acute Fatigue), Electrical Cardiometry, Biosignals
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 29 Aug 2017to 9 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epithelial ovarian cancer undergoing cytoreductive surgery
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin
Berlin, 13353
About this study
Official title: 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.
- Conditions
- Perioperative Early Tiredness (Acute Fatigue), Electrical Cardiometry, Biosignals, Mitochondrial Dysfunction, Nutrition
- Medical subject headings
- Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Acute Fatigue Score (AFS)
Rating of the AFS
Measured: 1 hour after the end of anaesthesia
Secondary outcomes (20)
Acute Fatigue Score (AFS)
Perioperative time course of the ratings of AFS
Measured: 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
Measured: 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
Measured: 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
Measured: Up to the fifth postoperative day
Hemodynamic variables obtained by Electrical Cardiometry (EC)
EC is a method of bioimpedance
Measured: 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
Measured: 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
Measured: 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
Measured: Up to the first postoperative day
Mitochondrial respiratory chain activities
Respiratory chain activities are assessed in muscle biopsies using high-resolution respirometry
Measured: 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
Measured: Up to the fifth postoperative day
Blood loss
Perioperative blood loss characteristics
Measured: Up to the fifth postoperative day
Body temperature
Body temperature will be assessed continuously and discontinuously
Measured: Up to the first postoperative day
Fluid balances
The balances between all orally and intravenously administered fluids and all fluid losses
Measured: 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
Measured: 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
Measured: Up to the fifth postoperative day
Organ dysfunctions and complications
Organ complications are classified according to Clavien-Dindo classification
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Participants will be followed up until hospital discharge (expected average of 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start29 Aug 2017
- Primary completion9 Oct 2018
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Early Tiredness (Acute Fatigue)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarne Feldheiser
- Sponsor type
- University, hospital or other
- Collaborators
- Experimental & Clinical Research Center Berlin, German Institute of Human Nutrition, Humboldt-Universität zu Berlin, Technische Universität Berlin
- Responsible party
- Sponsor-investigator, Aarne Feldheiser, Charite University, Berlin, Germany
- Investigators
- Oliver Hunsicker, MD, Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - University Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131102
- Sponsor's protocol ID
- PERISCOPE
- Acronym
- PERISCOPE
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2017
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Perioperative Early Tiredness (Acute Fatigue) With Hemodynamic, Immunologic, Endothelial, Metabolic, Gastrointestinal Measures and Complications in Patients With Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03131102
- Acronym / sponsor ID
- PERISCOPE / PERISCOPE
- Conditions
- Perioperative Early Tiredness (Acute Fatigue), Electrical Cardiometry, Biosignals, Mitochondrial Dysfunction, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aarne FeldheiserUniversity, hospital or other
- Collaborators
- Experimental & Clinical Research Center Berlin, German Institute of Human Nutrition, Humboldt-Universität zu Berlin, Technische Universität Berlin
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epithelial ovarian cancer undergoing cytoreductive surgery
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Fatigue Score (AFS)
Time frame: 1 hour after the end of anaesthesia
Rating of the AFS
20 secondary outcomes
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)
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)
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)
Hemodynamic variables and catecholamine administration
Time frame: Up to the fifth postoperative day
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)
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)
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)
Metabolomics/Proteomics
Time frame: Up to the first postoperative day
Mitochondrial respiratory chain activities
Time frame: Up to the first postoperative day
Nutrition associated antibodies and deficiency states of vitamins and trace elements
Time frame: Up to the fifth postoperative day
Blood loss
Time frame: Up to the fifth postoperative day
Body temperature
Time frame: Up to the first postoperative day
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)
Blood coagulation markers
Time frame: Up to the fifth postoperative day
Immunologic, endothelial and hepatic markers
Time frame: Up to the fifth postoperative day
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)
Microvascular function
Time frame: Up to the fifth postoperative day and at hospital discharge (an average of two weeks)
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)
Intensive care unit length of stay
Time frame: Participants will be followed up until intensive care unit discharge (an average of two days)
Hospital length of stay
Time frame: Participants will be followed up until hospital discharge (expected average of 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Hunsicker, MD principal investigator
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - University Medicine Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Early Tiredness (Acute Fatigue) and Electrical Cardiometry, run by Aarne Feldheiser at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Fatigue Score (AFS) (time frame: 1 hour after the end of anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.