Right Ventricular Function and Venous Return Clinical Trial
Official title:
Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (GynRight) - Pilot Study
| Verified date | July 2017 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 2017 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Primary | 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 | |
| Primary | Venous return | Venous return will be assessed perioperatively by venous return pressure gradient (dVR) | Up to the first postoperative day | |
| Secondary | Variables of transthoracic and transesophageal echocardiography | Perioperative course of variables of transthoracic and transesophageal echocardiography | Up to the first postoperative day | |
| Secondary | Venous return variables according to Guyton concept | Perioperative course of variables according to Guyton concept characterizing venous return | Up to the first postoperative day | |
| Secondary | Hemodynamic variables | Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor | Up to the third postoperative day | |
| Secondary | Catecholamine administration | Catecholamine administration intra- und postoperative | Up to the third postoperative day | |
| Secondary | Immunological parameter | Perioperative immunological (IL-6 und TNF-alpha) | Up to the third postoperative day | |
| Secondary | Endothelial parameter | Perioperative endothelial Parameter (ICAM-1) | Up to the third postoperative day | |
| Secondary | Microvascular function | Perioperative course of variables assessing microvascular function | Up to the first postoperative day | |
| Secondary | Blood loss | Blood loss characteristics intra- und postoperative | Up to the third postoperative day | |
| Secondary | Fluid balance | Fluid and volume administration and balance intra- und postoperative | Up to the third postoperative day | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Hospital length of stay | Participants will be followed up until hospital discharge, an average of two weeks | ||
| Secondary | Intensive care unit length of stay | Participants will be followed up until intensive crae unit discharge, an average of two days | ||
| Secondary | Quality of life | Assessed with EQ-5D questionnaire | Baseline and hospital discharge with an expected average of 14 days | |
| Secondary | 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 |