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

Withdrawn

• Conditions: Right Ventricular Function and Venous Return

• Registration Number: NCT02291276
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-14
• Primary Completion: 2016-11
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Venous return	Up to the first postoperative day	Venous return will be assessed perioperatively by venous return pressure gradient (dVR)
Right ventricular function	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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