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

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• Status: Withdrawn
• Conditions: Right Ventricular Function and Venous Return

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to the first postoperative day
Venous return	Venous return will be assessed perioperatively by venous return pressure gradient (dVR)	Up to the first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variables of transthoracic and transesophageal echocardiography	Perioperative course of variables of transthoracic and transesophageal echocardiography	Up to the first postoperative day
Venous return variables according to Guyton concept	Perioperative course of variables according to Guyton concept characterizing venous return	Up to the first postoperative day
Hemodynamic variables	Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor	Up to the third postoperative day
Catecholamine administration	Catecholamine administration intra- und postoperative	Up to the third postoperative day
Immunological parameter	Perioperative immunological (IL-6 und TNF-alpha)	Up to the third postoperative day
Endothelial parameter	Perioperative endothelial Parameter (ICAM-1)	Up to the third postoperative day
Microvascular function	Perioperative course of variables assessing microvascular function	Up to the first postoperative day
Blood loss	Blood loss characteristics intra- und postoperative	Up to the third postoperative day
Fluid balance	Fluid and volume administration and balance intra- und postoperative	Up to the third postoperative day
Organ complications	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	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		Participants will be followed up until hospital discharge, an average of two weeks
Intensive care unit length of stay		Participants will be followed up until intensive crae unit discharge, an average of two days
Quality of life	Assessed with EQ-5D questionnaire	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).	Baseline and hospital discharge with an expected average stay of 14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of right ventricular function index	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

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: GynRight