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

This study is currently recruiting participants.
Verified October 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01311297
First received: March 8, 2011
Last updated: October 30, 2013
Last verified: October 2013
  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
Study Director: Claudia Spies, MD Prof. 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: October 30, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on April 23, 2014