Right Ventricular Function and Venous ReturnNCT02291276
Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (Gyn Right) - Pilot Study
An observational study of Right Ventricular Function and Venous Return, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Right Ventricular Function and Venous Return
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- Patient Group 1: Female patients with > 500 ml ascites in the preoperative sonographic examination
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Berlin, 13353
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular function
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.
Measured: Up to the first postoperative day
Venous return
Venous return will be assessed perioperatively by venous return pressure gradient (dVR)
Measured: Up to the first postoperative day
Secondary outcomes (15)
Variables of transthoracic and transesophageal echocardiography
Perioperative course of variables of transthoracic and transesophageal echocardiography
Measured: Up to the first postoperative day
Venous return variables according to Guyton concept
Perioperative course of variables according to Guyton concept characterizing venous return
Measured: Up to the first postoperative day
Hemodynamic variables
Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor
Measured: Up to the third postoperative day
Catecholamine administration
Catecholamine administration intra- und postoperative
Measured: Up to the third postoperative day
Immunological parameter
Perioperative immunological (IL-6 und TNF-alpha)
Measured: Up to the third postoperative day
Endothelial parameter
Perioperative endothelial Parameter (ICAM-1)
Measured: Up to the third postoperative day
Microvascular function
Perioperative course of variables assessing microvascular function
Measured: Up to the first postoperative day
Blood loss
Blood loss characteristics intra- und postoperative
Measured: Up to the third postoperative day
Fluid balance
Fluid and volume administration and balance intra- und postoperative
Measured: Up to the third postoperative day
Organ complications
Postoperative organ complications are classified according to Clavien - Dindo classification
Measured: Participants will be followed up until hospital discharge, an average of two weeks
Postoperative pain
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)
Measured: Up to the third postoperative day
Hospital length of stay
Measured: Participants will be followed up until hospital discharge, an average of two weeks
Intensive care unit length of stay
Measured: Participants will be followed up until intensive crae unit discharge, an average of two days
Quality of life
Assessed with EQ-5D questionnaire
Measured: Baseline and hospital discharge with an expected average of 14 days
Functional status
Measured by the Barthel activities of daily living (ADL) index and activities of daily living (IADL).
Measured: Baseline and hospital discharge with an expected average stay of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular Function and Venous ReturnStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291276
- Sponsor's protocol ID
- GynRight
- Status last verified
- Jul 2017
- First submitted
- 7 Nov 2014
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (GynRight) - Pilot Study
- ClinicalTrials.gov ID
- NCT02291276
- Acronym / sponsor ID
- GynRight
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Venous return
Time frame: Up to the first postoperative day
Venous return will be assessed perioperatively by venous return pressure gradient (dVR)
15 secondary outcomes
Variables of transthoracic and transesophageal echocardiography
Time frame: Up to the first postoperative day
Venous return variables according to Guyton concept
Time frame: Up to the first postoperative day
Hemodynamic variables
Time frame: Up to the third postoperative day
Catecholamine administration
Time frame: Up to the third postoperative day
Immunological parameter
Time frame: Up to the third postoperative day
Endothelial parameter
Time frame: Up to the third postoperative day
Microvascular function
Time frame: Up to the first postoperative day
Blood loss
Time frame: Up to the third postoperative day
Fluid balance
Time frame: Up to the third postoperative day
Organ complications
Time frame: Participants will be followed up until hospital discharge, an average of two weeks
Postoperative pain
Time frame: 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
Intensive care unit length of stay
Time frame: 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
Functional status
Time frame: Baseline and hospital discharge with an expected average stay of 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Function and Venous Return, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular function (time frame: Up to the first postoperative day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.