Balanced crystalloids versus balanced colloids within a goal-directed hemodynamic protocol in patients undergoing gynaecological tumor resection.Balancierte Kristalloide versus balancierte Kolloide im Rahmen eines zielgerichteten Hämodynamik-Protokolls bei Patientinnen zur gynäkologischen Tumoroperatio
- Conditions
- The drugs Jonsteril and Volulyte6% will be investigated in female patients undergoing a tumor reduction operation. The study population will be female patients with metastatic ovarian carcinoma. The study medication will be administered and maintained according to a goal-directed hemodynamic protocol using an oesophagela Doppler during the operation.
- Registration Number
- EUCTR2008-006135-12-DE
- Lead Sponsor
- Charité- University Medicine Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
•Offered patient information and written informed consent
•No participation in another trial according to the German Drug Law at the study inclusion, during the study and not planned until the 10 th day postoperative
•Female Patients with metastatic ovarian carcinoma , who want to undergo a tumor reduction operation in the Universitätsklinik, Campus Virchow-Klinikum of the Charité – University Medicine Berlin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Age less than 18 years old
•Pregnancy or lactation
•Lacking willingness to save and hand out pseudonymised data within the study
•Accommodation in an institution due to an official or judicial order
•Advanced disease of the oesophagus of nasopharyngeal cavity
•Operations in the area of the oesophagus or nasopharynx within the last two months
•Liver disease (Child B or C cirrhosis, End-Stage Liver Disease [MELD] score greater than 10)
•Conditions after acute or chronic pancreatitis
•History of bleeding tendency
•Von Willebrands disease
•Neurological or psychiatric disease
•Unclear history of alcoholism
•Chronic heart failure class IV according to the New York Heart Association (NYHA)
•American Society of Anaesthesiologists (ASA) classification greater than III
•Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
•Existence of a pulmonary oedema in the preoperative chest x-ray
•Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions
•History of intracranial haemorrhage within one year before participation in the study
•Hyperkalaemia > 5,8 mmol / l and Hypernatriaemia > 155 mmol / l
•Praeoperative ileus symptomatology
•Known history of hypermagnesaemia
•Known history of metabolic alkalosis
•Derailed Diabetes mellitus (Glucose > 300 mg/dl) before inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method