Endothelial DysfunctionNCT01311297
Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course
An observational study of Endothelial Dysfunction, run by Claudia Spies at 1 site in Germany.
Trial summary
A single- center prospective observational study. This study evaluates different aspects of endothelial function. It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2011to 29 Sep 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin
Who may be able to join
- Offered patient information and written informed consent
- Female patients aged greater than or equal to 18 years:
- for reduction of a primary ovarian tumour or recidive of an ovarian tumour
- pregnant patients with:
- clinical normal pregnancy
- pregnancy with weight gain of more than 10 kg
- pregnancy and gestosis
- healthy volunteers
Who cannot join
- Persons without the capacity to consent
- Unability 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
Show all 17Show fewer
- Advanced disease of the oesophagus or upper respiratory tract
- Operation in the area of the oesophagus or nasopharynx within the last two months
- Neurological or psychiatric disease
- CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospital stay
- American Society of Anaesthesiologists (ASA) classification greater than IV
- Renal insufficiency (dependency of haemodialysis)
- Pulmonal oedema in thorax x-ray
- History of intracranial hemorrhage within one year of participation in the study
- Conditions following venous thrombosis within the last three years before study inclusion
- Inflammatory or reflective disease of blood vessels (Raynaud-Syndrome, Vasculitis)
- Inherent connective tissue disease(e.g. Marfan Syndrome)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Berlin, 13353
About this study
Official title: Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study
A single- center prospective observational study. This study evaluates different aspects of endothelial function. It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.
- Conditions
- Endothelial Dysfunction
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 |
|---|---|---|
| Perioperative ovarian cancer patients | Not described | |
| Pregnant patients | Not described | |
| Female healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filtration coefficient
Endothelial parameter from the examination with venous occlusion plethysmography.
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Filtration coefficient
Endothelial parameter from the examination with venous occlusion plethysmography.
Measured: up to one hour single measurement in pregnant woman
Secondary outcomes (14)
All patients: Hemodynamic parameters
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
All patients: Endothelial flow-mediated vasodilatation
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Blood loss
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
Measured: during the operation
Perioperative patients: Incidence and impact of organ dysfunctions
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Pain
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Body weight
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist
Measured: on the day of surgery
Perioperative patients: Duration until clinical discharge criteria were satisfied
Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Intensive care unit average length of stay; hospital average length of stay
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Quality of life
Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension.
Measured: perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
Pregnant patients: History data of the pregnancy, parameter of Gestosis
Gestosis: toxemia of pregnancy
Measured: up to one hour single measurement in pregnant woman
All patients: Immunological Markers
Differences in selected immunologic parameters among others IL-6, IL-10
Measured: perioperatively up to the fifth postoperative day in patients undergoing surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study start29 Mar 2011
- Primary completion29 Sep 2012
- Study completion29 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Spies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311297
- Sponsor's protocol ID
- POPEYE
- Status last verified
- May 2018
- First submitted
- 8 Mar 2011
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Feldheiser A, Dathe JJ, Heinig S, Pietzner K, Kaufner L, Hunsicker O, von Haefen C, Sehouli J, Spies C. Perioperative micro-arterial function and extravasation in cytoreductive ovarian cancer surgery: an observational study. Intensive Care Med Exp. 2026 Jan 25;14(1):7. doi: 10.1186/s40635-025-00839-4.
PubMed 41580514
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study
- ClinicalTrials.gov ID
- NCT01311297
- Acronym / sponsor ID
- POPEYE
- Conditions
- Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Claudia SpiesUniversity, hospital or other
- Study start
- 29 Mar 2011 (actual)
- Primary completion
- 29 Sep 2012 (actual)
- Study completion
- 29 Sep 2012 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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.
A single- center prospective observational study. This study evaluates different aspects of endothelial function. It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perioperative ovarian cancer patients | – | – |
| Pregnant patients | – | – |
| Female healthy volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin
Key inclusion criteria (8 listed)
- Offered patient information and written informed consent
- Female patients aged greater than or equal to 18 years:
Key exclusion criteria (17 listed)
- Persons without the capacity to consent
- Unability 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
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
Filtration coefficient
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Endothelial parameter from the examination with venous occlusion plethysmography.
Filtration coefficient
Time frame: up to one hour single measurement in pregnant woman
Endothelial parameter from the examination with venous occlusion plethysmography.
14 secondary outcomes
All patients: Hemodynamic parameters
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
All patients: Endothelial flow-mediated vasodilatation
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Blood loss
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
Time frame: during the operation
Perioperative patients: Incidence and impact of organ dysfunctions
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Pain
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Body weight
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist
Time frame: on the day of surgery
Perioperative patients: Duration until clinical discharge criteria were satisfied
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Intensive care unit average length of stay; hospital average length of stay
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Quality of life
Time frame: perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
Pregnant patients: History data of the pregnancy, parameter of Gestosis
Time frame: up to one hour single measurement in pregnant woman
All patients: Immunological Markers
Time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Derived from this study: PubMed 41580514Feldheiser A, Dathe JJ, Heinig S, Pietzner K, Kaufner L, Hunsicker O, von Haefen C, Sehouli J, Spies C. Perioperative micro-arterial function and extravasation in cytoreductive ovarian cancer surgery: an observational study. Intensive Care Med Exp. 2026 Jan 25;14(1):7. doi: 10.1186/s40635-025-00839-4.
Related trials for Endothelial Dysfunction
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
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.
Claudia Spies, MD Prof. study director
Charite University, Berlin, Germany
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 Endothelial Dysfunction, run by Claudia Spies 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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 25 May 2018. 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 was stopped early. Results are not available in the source record.
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?
Filtration coefficient (time frame: perioperatively up to the fifth postoperative day in patients undergoing surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311297, which also lists 1 linked publication.
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 25 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.