Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (GynRight) - Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Right Ventricular Function and Venous Return
- Sponsor
- Charite University, Berlin, Germany
- Locations
- 1
- Primary Endpoint
- Venous return
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
Claudia Spies
Univ.- Prof. Dr. Claudia Spies
Charite University, Berlin, Germany
Eligibility 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
- •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
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
Outcomes
Primary Outcomes
Venous return
Time Frame: Up to the first postoperative day
Venous return will be assessed perioperatively by venous return pressure gradient (dVR)
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.
Secondary Outcomes
- Venous return variables according to Guyton concept(Up to the first postoperative day)
- Organ complications(Participants will be followed up until hospital discharge, an average of two weeks)
- Immunological parameter(Up to the third postoperative day)
- Endothelial parameter(Up to the third postoperative day)
- Microvascular function(Up to the first postoperative day)
- Functional status(Baseline and hospital discharge with an expected average stay of 14 days)
- 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)
- Postoperative pain(Up to the third postoperative day)
- Hemodynamic variables(Up to the third postoperative day)
- Catecholamine administration(Up to the third postoperative day)
- Blood loss(Up to the third postoperative day)
- Fluid balance(Up to the third postoperative day)
- Quality of life(Baseline and hospital discharge with an expected average of 14 days)
- Intensive care unit length of stay(Participants will be followed up until intensive crae unit discharge, an average of two days)