Endothelial Dysfunction
Conditions
Brief 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.
Interventions
None listed
Sponsors
Claudia Spies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Filtration coefficient | perioperatively up to the fifth postoperative day in patients undergoing surgery | Endothelial parameter from the examination with venous occlusion plethysmography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF) | perioperatively up to the fifth postoperative day in patients undergoing surgery | — |
| All patients: Endothelial flow-mediated vasodilatation | perioperatively up to the fifth postoperative day in patients undergoing surgery | — |
| Perioperative patients: Blood loss | perioperatively up to the fifth postoperative day in patients undergoing surgery | — |
| Perioperative patients: Parameter of monitored sedation (BIS - Monitoring) | during the operation | — |
| Perioperative patients: Incidence and impact of organ dysfunctions | perioperatively up to the fifth postoperative day in patients undergoing surgery | — |
| Perioperative patients: Pain | 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) |
| All patients: Hemodynamic parameters | perioperatively up to the fifth postoperative day in patients undergoing surgery | — |
| Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist | on the day of surgery | — |
| Perioperative patients: Duration until clinical discharge criteria were satisfied | perioperatively up to the fifth postoperative day in patients undergoing surgery | Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness |
| Perioperative patients: Intensive care unit average length of stay; hospital average length of stay | perioperatively up to the fifth postoperative day in patients undergoing surgery | — |
| Perioperative patients: Quality of life | 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. |
| Pregnant patients: History data of the pregnancy, parameter of Gestosis | up to one hour single measurement in pregnant woman | Gestosis: toxemia of pregnancy |
| All patients: Immunological Markers | perioperatively up to the fifth postoperative day in patients undergoing surgery | Differences in selected immunologic parameters among others IL-6, IL-10 |
| Perioperative patients: Body weight | perioperatively up to the fifth postoperative day in patients undergoing surgery | — |
Countries
Germany
Outcome results
None listed