Status:
WITHDRAWN
Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (Gyn Right) - Pilot Study
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Right Ventricular Function and Venous Return
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02291276
Start Date
November 1 2014
End Date
April 1 2017
Last Update
July 19 2017
Active Locations (1)
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1
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Berlin, Germany, 13353