Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course

May 24, 2018 updated by: Claudia Spies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin

Description

Inclusion Criteria:

  • Offered patient information and written informed consent

  • Female patients aged greater than or equal to 18 years:

    1. for reduction of a primary ovarian tumour or recidive of an ovarian tumour

    2. pregnant patients with:

      • clinical normal pregnancy
      • pregnancy with weight gain of more than 10 kg
      • pregnancy and gestosis
    3. healthy volunteers

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Perioperative ovarian cancer patients
Pregnant patients
Female healthy volunteers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Filtration coefficient
Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Endothelial parameter from the examination with venous occlusion plethysmography.
perioperatively up to the fifth postoperative day in patients undergoing surgery
Filtration coefficient
Time Frame: up to one hour single measurement in pregnant woman
Endothelial parameter from the examination with venous occlusion plethysmography.
up to one hour single measurement in pregnant woman

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All patients: Hemodynamic parameters
Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
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
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
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
perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
Time Frame: during the operation
during the operation
Perioperative patients: Incidence and impact of organ dysfunctions
Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery
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
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
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
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
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
Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
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
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
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.
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
Gestosis: toxemia of pregnancy
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
Differences in selected immunologic parameters among others IL-6, IL-10
perioperatively up to the fifth postoperative day in patients undergoing surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Claudia Spies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POPEYE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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