Impact of a balanced infusion solution compound of 50% cristalloid and 50% colloid versus a unbalanced infusion solution of 100% cristalloid within a goal-directed hemodynamic protocol on acid-base balance in patients undergoing elective hip replacement surgeryAuswirkung der Anwendung einer balancierten Infusionslösungsmischung aus 50% kolloidaler und 50% kristalloider Lösung versus einer unbalancierten 100% kristalloiden Lösung innerhalb eines zielgerichteten Hämodynamik-Protokolls auf den Säure-Base Haushalt bei Patienten zur elektiven Hüfttotalendoprothese. - HIPSTER

• Conditions: 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.

• Registration Number: EUCTR2009-016043-19-DE
• Lead Sponsor: Charité – University Medicine Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-09
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified