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

Terminated

• Conditions: Endothelial Dysfunction

• Registration Number: NCT01311297
• Lead Sponsor: Claudia Spies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Study Start: 2011-03-29
• Primary Completion: 2012-09-29
• Study Completion: 2012-09-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 47

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Filtration coefficient	up to one hour single measurement in pregnant woman	Endothelial parameter from the examination with venous occlusion plethysmography.

Secondary Outcome Measures

Name	Time	Method
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: Incidence and impact of organ dysfunctions	perioperatively up to the fifth postoperative day in patients undergoing surgery
Perioperative patients: Pain	perioperatively up to the fifth postoperative day in patients undergoing surgery	Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
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	perioperatively up to the fifth postoperative day in patients undergoing surgery	Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
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	perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks	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.
Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)	during the operation
All patients: Immunological Markers	perioperatively up to the fifth postoperative day in patients undergoing surgery	Differences in selected immunologic parameters among others IL-6, IL-10
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
Pregnant patients: History data of the pregnancy, parameter of Gestosis	up to one hour single measurement in pregnant woman	Gestosis: toxemia of pregnancy

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin; 🇩🇪 Berlin, Germany