Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

Study Overview
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Brief Summary
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The investigators aimed to compare the costs and consequences of 'routine perioperative fluid therapy' and 'GDHT in terms of morbidity, mortality, length of hospital stay, activity of daily living, health related quality of life, cognitive functions and need of social services and up till 12 months following operations of proximal femoral fracture at elderly. The primary hypothesis is that 'GDHT is a better strategy than 'routine fluid therapy' in terms of reduced frequency of postoperative complications.

Detailed Description
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The investigation is an open, randomized clinical study of individuals suffering from a proximal femoral fracture. The total study duration for each subject is approximately 12 months (+- 1 month); each patient will have 4'visits' (i.e. when PI extracts data to database) including regular praxis total: at registration; at discharge; 4 months and finally at 12 months after the surgery. For practical and logistic reasons, an interim-analysis will be conducted after approximately 100 patients whose data are completed.

Official Title
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Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial

Conditions
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Femoral Fracture

Intervention / Treatment
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* Other: Goal directed haemodynamic treatment
* Other: Routine fluid treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (men and women) age ≥ 70 years Patients´ scheduled for operation of proximal femoral fracture during office hours Patient who have a witnessed or written informed consent Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study: Concomitant medication with Lithium Known allergy (or hypersensitivity) to Lithium, or components of the medical device Weight ≤ 40 kg Other conditions or symptoms preventing the subject from entering the study, according to investigators judgment Life expectancy less than 6 months and/or pathological fractures Not possible to insert arterial line.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine fluid treatment<br>Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h and additionally as needed Voluven at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension | Other: Routine fluid treatment<br>* Protocol guided fluid treatment used in the clinical routine<br>* Other names: Phenylephrine 50 μg for correction of hypotension;|
| Experimental: Goal directed haemodynamic treatment<br>Goal directed haemodynamic treatment Dobutamine 0.2-10 μg/kg/min Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h Voluven 3 ml/kg as fluid challenge at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension | Other: Goal directed haemodynamic treatment<br>* Treatment by fluids and Dobutamine to attain fixed haemodynamic goal<br>* Other names: Phenylephrine 50 μg for correction of hypotension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with postoperative complications | absolute value, number | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively | 1 year | 
| number of complications | absolute value number | 4 months | 
| number of complications | absolute value number | 12 months | 
| health related quality of life |  | 4 months | 
| health related quality of life | absolute value number | 12 months | 
| haemodynamic parameters | monitor readings from LiDCO plus | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal Femoral Fracture