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


N/A
18 Years
N/A
Open (Enrolling)
Female
Endothelial Dysfunction

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Trial Information

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


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Filtration coefficient

Outcome Description:

Endothelial parameter from the examination with venous occlusion plethysmography.

Outcome Time Frame:

perioperatively up to the fifth postoperative day in patients undergoing surgery

Safety Issue:

No

Principal Investigator

Claudia Spies, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University, Berlin, Germany

Authority:

Germany: Ethics Commission

Study ID:

POPEYE

NCT ID:

NCT01311297

Start Date:

March 2011

Completion Date:

October 2014

Related Keywords:

  • Endothelial Dysfunction

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