Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - Full Text View

Purpose

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.

Condition
Endothelial Dysfunction

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Filtration coefficient [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
Endothelial parameter from the examination with venous occlusion plethysmography.
Filtration coefficient [ Time Frame: up to one hour single measurement in pregnant woman ] [ Designated as safety issue: No ]
Endothelial parameter from the examination with venous occlusion plethysmography.

Secondary Outcome Measures:

All patients: Hemodynamic parameters [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF) [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
All patients: Endothelial flow-mediated vasodilatation [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
Perioperative patients: Blood loss [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: Yes ]
Perioperative patients: Parameter of monitored sedation (BIS - Monitoring) [ Time Frame: during the operation ] [ Designated as safety issue: Yes ]
Perioperative patients: Incidence and impact of organ dysfunctions [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: Yes ]
Perioperative patients: Pain [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: Yes ]
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
Perioperative patients: Body weight [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist [ Time Frame: on the day of surgery ] [ Designated as safety issue: No ]
Perioperative patients: Duration until clinical discharge criteria were satisfied [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
Perioperative patients: Intensive care unit average length of stay; hospital average length of stay [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
Perioperative patients: Quality of life [ Time Frame: perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: up to one hour single measurement in pregnant woman ] [ Designated as safety issue: No ]
Gestosis: toxemia of pregnancy
All patients: Immunological Markers [ Time Frame: perioperatively up to the fifth postoperative day in patients undergoing surgery ] [ Designated as safety issue: No ]
Differences in selected immunologic parameters among others IL-6, IL-10

Biospecimen Retention: Samples Without DNA

Whole blood, serum

Estimated Enrollment:	90
Study Start Date:	March 2011
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Perioperative ovarian cancer patients
Pregnant patients
Female healthy volunteers

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311297

Contacts

Contact: Claudia Spies, MD Prof.

+49 30 450 551001

claudia.spies@charite.de

Locations

Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin	Recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, MD, Prof. +49 30 450 551001 claudia.spies@charite.de
Sub-Investigator: Aarne Feldheiser, MD

Sponsors and Collaborators

Claudia Spies

Investigators

Principal Investigator:

Claudia Spies, Prof. Dr.

Charite University, Berlin, Germany

More Information

No publications provided

Responsible Party:	Claudia Spies, Prof. , MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01311297 History of Changes
Other Study ID Numbers:	POPEYE
Study First Received:	March 8, 2011
Last Updated:	April 18, 2013
Health Authority:	Germany: Ethics Commission

ClinicalTrials.gov processed this record on May 22, 2013