Clinical trial NCT02291276: Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (Gyn Right) - Pilot Study
Official title: Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (GynRight) - Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Right Ventricular Function and Venous Return
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

  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.

Primary outcomes:
measure: Right ventricular function
timeFrame: Up to the first postoperative day
measure: Venous return
timeFrame: Up to the first postoperative day
Secondary outcomes:
measure: Variables of transthoracic and transesophageal echocardiography
timeFrame: Up to the first postoperative day
measure: Venous return variables according to Guyton concept
timeFrame: Up to the first postoperative day
measure: Hemodynamic variables
timeFrame: Up to the third postoperative day
measure: Catecholamine administration
timeFrame: Up to the third postoperative day
measure: Immunological parameter
timeFrame: Up to the third postoperative day
measure: Endothelial parameter
timeFrame: Up to the third postoperative day
measure: Microvascular function
timeFrame: Up to the first postoperative day
measure: Blood loss
timeFrame: Up to the third postoperative day
measure: Fluid balance
timeFrame: Up to the third postoperative day
measure: Organ complications
timeFrame: Participants will be followed up until hospital discharge, an average of two weeks
measure: Postoperative pain
timeFrame: Up to the third postoperative day
measure: Hospital length of stay
timeFrame: Participants will be followed up until hospital discharge, an average of two weeks
measure: Intensive care unit length of stay
timeFrame: Participants will be followed up until intensive crae unit discharge, an average of two days
measure: Quality of life
timeFrame: Baseline and hospital discharge with an expected average of 14 days
measure: Functional status
timeFrame: Baseline and hospital discharge with an expected average stay of 14 days
Other outcomes:
measure: Evaluation of right ventricular function index
timeFrame: Up to the first postoperative day
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: