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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 8, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 8, 2014
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on July 22, 2014