Impact of Fluid Management Within a Goal-directed Hemodynamic Protocol on Acid-base Balance in Elective Trauma Surgery

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the administration of a compound of balanced infusion solutions including 50% crystalloid and 50% colloid has a positive impact on acid-base balance in elective hip replacement surgery. The application of the study medication will be carried out through a goal-directed intraoperative therapy by transoesophageal doppler.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients at the age of 60 and above who want to undergo an elective hip replacement surgery in the center of musculoskeletal surgery

• Offered patient information and written informed consent

Exclusion Criteria:

• Participation in another trial according to the German Drug Law 30 days to and during the study

• Lacking willingness to save and hand out 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 anaesthesia

• American Society of Anaesthesiologists (ASA) classification greater than III

• Peripheral or 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, thrombocytopenia)

• 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, Hypernatraemia > 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 pancreatitis

• Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)