Clinical trial NCT01311297: Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course
Official title: Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Endothelial Dysfunction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Filtration coefficient
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Filtration coefficient
timeFrame: up to one hour single measurement in pregnant woman
Secondary outcomes:
measure: All patients: Hemodynamic parameters
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: All patients: Endothelial flow-mediated vasodilatation
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Perioperative patients: Blood loss
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
timeFrame: during the operation
measure: Perioperative patients: Incidence and impact of organ dysfunctions
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Perioperative patients: Pain
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Perioperative patients: Body weight
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist
timeFrame: on the day of surgery
measure: Perioperative patients: Duration until clinical discharge criteria were satisfied
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Perioperative patients: Intensive care unit average length of stay; hospital average length of stay
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
measure: Perioperative patients: Quality of life
timeFrame: perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
measure: Pregnant patients: History data of the pregnancy, parameter of Gestosis
timeFrame: up to one hour single measurement in pregnant woman
measure: All patients: Immunological Markers
timeFrame: perioperatively up to the fifth postoperative day in patients undergoing surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References: