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

NCT ID: NCT01311297

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-29
• Study Completion Date: 2012-09-29

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.

Conditions

Endothelial Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Perioperative ovarian cancer patients

No interventions assigned to this group

Pregnant patients

No interventions assigned to this group

Female healthy volunteers

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Claudia Spies

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Prof. , MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia Spies, MD Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin

Berlin, , Germany

Countries

Germany

Other Identifiers

POPEYE

Identifier Type: -

Identifier Source: org_study_id