Patients undergoing elective hip replacement surgery will be divided into two groups. In one group an intravenous application of Ringer Baxter Infusionsloesung, in the other group a parallel intravenous administration of Plasmalyt Infusionsloesung and PlasmaVolume Redibag will be used. The study medication will be administered and maintained according to a goal-directed hemodynamic protocol using an oesophageal doppler during the operation.
Conditions
Interventions
Trade Name: Ringer Baxter Infusionsloesung
Product Name: Ringer Baxter Infusionsloesung
Pharmaceutical Form: Solution for infusion
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE
Concent
Sponsors
Charité – University Medicine Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients at the age of 60 and above who want to undergo an elective hip replacement surgery in the center of muscoloskeletal surgery, Campus Charité Mitte, Charité - University Medicine Berlin. - Offered patient information and written informed consent 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: - Participation in another trial according to the German Drug Law 30 days prior to and during the study - Lacking willingness to save and hand out pseudonymised data within the study - Accommodation in an institution due to an official or judicial order - (unclear) history of alcohol or substances disabuse - absent knowledge of german language - analphabetism - Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions - for women: Pregnancy or positive pregnancy test within the preoperative screening - operation due to case of emergency, polytrauma or pathologic fracture - only use of regional anesthetics - American Society of Anaesthesiologists (ASA) classification greater than III - peripheral and central edema - AIDS (according to the CDC-classification of HIV-infection: category C) - rheumatoid disease under treatment with Anti-TNF-alpha-Ab and/or high-dose-corticoid-treatment - immunosuppression therapy - history of bleeding tendency (e.g. von-Willebrand-disease, thromobocytopenia) - derailed metabolic disorder (e.g. Diabetes mellitus (Glucose > 300 mg/dl) during the preoperative screening) - known history of electrolyte disturbance (e.g. Hyperkalemia > 5.8 mmol/l, Hypernatriaemia > 155 mmol/l) - known history of acid-base-dysbalances - history of intracranial hemorrhage within one year of participation in the study - neurological or psychiatric disease with limited contractual capability - advanced disease of the oesophagus or upper respiratory tract - operation in the area of the oesophagus or nasopharynx within the last two months - CHF (congestive heart failure) according to (new york heart association) classification - NYHA class IV - liver disease (CHILD B or C cirrhosis, end-stage liver disease (MELD-score greater than 10) - conditions after acute or chronic pancreatititis - renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change of standardized base excess after 2 litres of study medication.;Secondary Objective: 1. Change of the SID (strong ion difference) according to the stewart-approach of evaluating acid-base-dysbalances. 2. Doses und duration of therapy with catecholamines, number and duration of hypotensie episodes. 3. The quantity of fluids per day losing by drainage during the first three days after surgery. 4. Time until fullfilling the hospital discharge criteria (measured by PADSS) and length of hospital stay. 5. (Cumulative) frequency of postoperative organ dysfunctions (cerebral, cardiac, pulmonary, renal, gastrointestinal) 6. Daily course of the body weight until the fifth postoperative day. 7. Perioperative Incidence of infections (according to the Centers of disease control and prevention [CDC]). 8. Perioperative quality of life (e.g. EQ-5D). 9. Pain of the patient 10. Satisfaction of the patients, the anesthetist and the surgeon. 11. Laboratory parameters of function of the cardiovascular, renal and immune system.;Primary end point(s): Change in standardized base excess after administration of 2 litres of study medication. | — |
Countries
Germany
Outcome results
None listed