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

July 18, 2017 updated by: Claudia Spies, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to the first postoperative day
Venous return
Time Frame: Up to the first postoperative day
Venous return will be assessed perioperatively by venous return pressure gradient (dVR)
Up to the first postoperative day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Variables of transthoracic and transesophageal echocardiography
Time Frame: Up to the first postoperative day
Perioperative course of variables of transthoracic and transesophageal echocardiography
Up to the first postoperative day
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
Up to the first postoperative day
Hemodynamic variables
Time Frame: Up to the third postoperative day
Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor
Up to the third postoperative day
Catecholamine administration
Time Frame: Up to the third postoperative day
Catecholamine administration intra- und postoperative
Up to the third postoperative day
Immunological parameter
Time Frame: Up to the third postoperative day
Perioperative immunological (IL-6 und TNF-alpha)
Up to the third postoperative day
Endothelial parameter
Time Frame: Up to the third postoperative day
Perioperative endothelial Parameter (ICAM-1)
Up to the third postoperative day
Microvascular function
Time Frame: Up to the first postoperative day
Perioperative course of variables assessing microvascular function
Up to the first postoperative day
Blood loss
Time Frame: Up to the third postoperative day
Blood loss characteristics intra- und postoperative
Up to the third postoperative day
Fluid balance
Time Frame: Up to the third postoperative day
Fluid and volume administration and balance intra- und postoperative
Up to the third postoperative day
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
Participants will be followed up until hospital discharge, an average of two weeks
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)
Up to the third postoperative day
Hospital length of stay
Time Frame: Participants will be followed up until hospital discharge, an average of two weeks
Participants will be followed up until hospital discharge, an average of two weeks
Intensive care unit length of stay
Time Frame: Participants will be followed up until intensive crae unit discharge, an average of two days
Participants will be followed up until intensive crae unit discharge, an average of two days
Quality of life
Time Frame: Baseline and hospital discharge with an expected average of 14 days
Assessed with EQ-5D questionnaire
Baseline and hospital discharge with an expected average of 14 days
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).
Baseline and hospital discharge with an expected average stay of 14 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to the first postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GynRight

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