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.
Conditions
Interventions
Trade Name: Jonosteril
Product Name: Jonosteril
Pharmaceutical Form: Intravenous infusion
Trade Name: Volulyte 6%
Product Name: Volulyte 6%
Pharmaceutical Form: Intravenous infusion
INN or Proposed I
Sponsors
Charité- University Medicine Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Differences of intravenous administered amount of fluids (Volulyte vs. Jonosteril) intraoperatively within a goal-directed hemodynamic protocol;Primary end point(s): Quantity of fluid administered intravenously during the operation within a goal-directed hemodynamic protocol (Volulyte versus Jonosteril);Secondary Objective: Doses and duration of therapy with catecholamines, time and number of hypotensive episodes The quantity of intravenous fluid administered to the patient during the first 18 hours after surgery The quantity of fluids per day loosing by drainage during the first three days after surgery Time until fulfilling the hospital discharge criteria (measured by PADSS) and length of stay in the hospital The rate of postoperative organ dysfunctions and complications (cardiac, pulmonary, gastrointestinal and renal dysf.) The rate of postoperative complications (delirium) and the postoperative incidence of postoperative, cognitive dysfunction (POCD) Daily course of the body weight until the fifth postoperative day Incidence of infections Satisfaction of the patients, the anaesthesist, the surgeon Pain of the patient Quality of life before the operation, at the day of hospital discharge and 3 months after surgery Parameters of immune and endothelial function | — |
Countries
Germany
Outcome results
None listed