Clinical trial NCT01117519: Impact of Fluid Management Within a Goal-directed Hemodynamic Protocol on Acid-base Balance in Elective Trauma Surgery
Official title: Impact of a Balanced Infusion Solution Compound of 50% Crystalloid and 50% Colloid Versus an Unbalanced Infusion Solution of 100% Crystalloid Within a Goal-directed Hemodynamic Protocol on Acid-base Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Instability
Keywords: fluid and volume management
acid-base balance
goal-directed therapy
transoesophageal doppler
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Standard Base Excess
timeFrame: up to 2 days
Secondary outcomes:
measure: SID (strong ion difference)
timeFrame: up to 2 days
measure: Hemodynamic Stability
timeFrame: up to 6 days
measure: Fluid Loss of Drainage
timeFrame: up to 6 days
measure: Discharge Criteria, Length of Hospital Stay
timeFrame: 5 days up to hospital discharge
measure: Organ Function/Dysfunction
timeFrame: up to 6 days
measure: Incidence of Infections
timeFrame: up to 5 days
measure: Pain
timeFrame: up to 6 days
measure: Incidence of Delirium
timeFrame: up to 6 days
measure: Incidence of Postoperative Cognitive Deficit (POCD)
timeFrame: up to 90 days after surgery
measure: Mobilisation
timeFrame: up to 6 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: