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

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

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.

Study Overview

• Status: Terminated
• Conditions: Endothelial Dysfunction

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Perioperative ovarian cancer patients
Pregnant patients
Female healthy volunteers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Claudia Spies

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2011
• Primary Completion (Actual): September 29, 2012
• Study Completion (Actual): September 29, 2012

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 9, 2011

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 24, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: POPEYE