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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study

Conditions
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Endothelial Dysfunction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perioperative ovarian cancer patients<br> | |
| Pregnant patients<br> | |
| Female healthy volunteers<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filtration coefficient | Endothelial parameter from the examination with venous occlusion plethysmography. | perioperatively up to the fifth postoperative day in patients undergoing surgery | 
| Filtration coefficient | Endothelial parameter from the examination with venous occlusion plethysmography. | up to one hour single measurement in pregnant woman | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All patients: Hemodynamic parameters |  | perioperatively up to the fifth postoperative day in patients undergoing surgery | 
| 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 | 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 |  | 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 | 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 |  | 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. | 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 | up to one hour single measurement in pregnant woman | 
| All patients: Immunological Markers | Differences in selected immunologic parameters among others IL-6, IL-10 | perioperatively up to the fifth postoperative day in patients undergoing surgery |