EUCTR2009-016043-19-DE进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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)
研究者
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