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Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (Gyn Right) - Pilot Study

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ClinicalTrials.gov Identifier: NCT02291276
Recruitment Status : Withdrawn
First Posted : November 14, 2014
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Brief Summary:
In this prospective, observational study the investigators assess the perioperative course of right ventricular function in combination with the venous return in patients undergoing major non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac surgery develop an impairment of right ventricular function and/or venous return. Furthermore, the study evaluates if an impairment of right ventricular function and/or venous return is associated to left ventricular function, arterial side of the circulation and to postoperative clinical outcome.

Condition or disease
Right Ventricular Function and Venous Return

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (GynRight) - Pilot Study
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Female cancer patients with ascites
Primary epithelial ovarian female cancer patients with ascites (> 500 ml ascites in the preoperative sonographic examination)
Female cancer patients aged > 70 years

Primary epithelial ovarian female cancer patients aged > 70 years with at least one of the following secondary diagnoses:

  • Status Post stent placement due to coronary heart disease respectively Status Post-myocardial infarction
  • existing arterial Hypertension for more than 5 years
  • chronic heart failure (New York Heart Association (NYHA) class II-III)
  • peripheral arterial disease



Primary Outcome Measures :
  1. Right ventricular function [ Time Frame: Up to the first postoperative day ]
    Right ventricular function will be measured perioperatively by a combination of right ventricular stroke volume, tricuspid annular plane systolic excursion (TAPSE), hepatic venous blood flow, variations in diameter of vena cavae, and right ventricle/left ventricle-ratio.

  2. Venous return [ Time Frame: Up to the first postoperative day ]
    Venous return will be assessed perioperatively by venous return pressure gradient (dVR)


Secondary Outcome Measures :
  1. Variables of transthoracic and transesophageal echocardiography [ Time Frame: Up to the first postoperative day ]
    Perioperative course of variables of transthoracic and transesophageal echocardiography

  2. Venous return variables according to Guyton concept [ Time Frame: Up to the first postoperative day ]
    Perioperative course of variables according to Guyton concept characterizing venous return

  3. Hemodynamic variables [ Time Frame: Up to the third postoperative day ]
    Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor

  4. Catecholamine administration [ Time Frame: Up to the third postoperative day ]
    Catecholamine administration intra- und postoperative

  5. Immunological parameter [ Time Frame: Up to the third postoperative day ]
    Perioperative immunological (IL-6 und TNF-alpha)

  6. Endothelial parameter [ Time Frame: Up to the third postoperative day ]
    Perioperative endothelial Parameter (ICAM-1)

  7. Microvascular function [ Time Frame: Up to the first postoperative day ]
    Perioperative course of variables assessing microvascular function

  8. Blood loss [ Time Frame: Up to the third postoperative day ]
    Blood loss characteristics intra- und postoperative

  9. Fluid balance [ Time Frame: Up to the third postoperative day ]
    Fluid and volume administration and balance intra- und postoperative

  10. Organ complications [ Time Frame: Participants will be followed up until hospital discharge, an average of two weeks ]
    Postoperative organ complications are classified according to Clavien - Dindo classification

  11. Postoperative pain [ Time Frame: Up to the third postoperative day ]
    Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI)

  12. Hospital length of stay [ Time Frame: Participants will be followed up until hospital discharge, an average of two weeks ]
  13. Intensive care unit length of stay [ Time Frame: Participants will be followed up until intensive crae unit discharge, an average of two days ]
  14. Quality of life [ Time Frame: Baseline and hospital discharge with an expected average of 14 days ]
    Assessed with EQ-5D questionnaire

  15. Functional status [ Time Frame: Baseline and hospital discharge with an expected average stay of 14 days ]
    Measured by the Barthel activities of daily living (ADL) index and activities of daily living (IADL).


Other Outcome Measures:
  1. Evaluation of right ventricular function index [ Time Frame: Up to the first postoperative day ]
    Right ventricular function index will be evaluated by a combination of right ventricular stroke volume, tricuspid annular plane systolic excursion (TAPSE), hepatic venous blood flow, variations in diameter of vena cavae and right ventricle/left ventricle-ratio.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female cancer patients being observed in the Department of Anesthesiology and Intensive Care Medicine CVK and CCM in cooperation with the Department of Gynecology and Obstetrics CVK at the 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 for cytoreductive surgery of a primary epithelial ovarian tumour

    1. Patient Group 1: Female patients with > 500 ml ascites in the preoperative sonographic examination
    2. Patient group 2: Female patients aged > 70 years and at least one of the following secondary diagnoses:

      • Status Post stent placement due to coronary heart disease respectively Status Post-myocardial infarction
      • existing arterial Hypertension for more than 5 years
      • chronic heart failure (New York Heart Association (NYHA) class II-III)
      • peripheral arterial disease

Exclusion Criteria:

  • Patients aged less than 18 years
  • Persons without the capacity to consent
  • Inability 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 at the beginning of hospitalization
  • Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study
  • Neurological or psychiatric disease at the beginning of hospitalization
  • CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalization
  • American Society of Anesthesiologists (ASA) classification greater than IV
  • Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization
  • Pulmonary oedema in thorax x-ray at the beginning of hospitalization
  • History of intracranial hemorrhage within one year before participation in the study
  • Conditions following venous thrombosis within the last three years before study inclusion
  • Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions
  • Diabetes mellitus with signs of severe neuropathy
  • Known atrial fibrillation
  • Participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291276


Locations
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Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Study Director: Claudia Spies, MD, Prof. Charite University, Berlin, Germany
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Responsible Party: Claudia Spies, Univ.- Prof. Dr. Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02291276    
Other Study ID Numbers: GynRight
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type