Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture (GDHT)

• Health Related Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively
• number of complications [ Time Frame: 4 months ] [ Designated as safety issue: No ]
• number of complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• health related quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
• health related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• haemodynamic parameters [ Time Frame: baseline ] [ Designated as safety issue: No ]

• Health Related Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  EQ5D questionaire shall be registered preoperatively, at 4 and 12 months postoperatively
• number of complications [ Time Frame: 4 months ] [ Designated as safety issue: No ]
• number of complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• health related quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
• health related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• haemodynamic parameters [ Time Frame: baseline ] [ Designated as safety issue: No ]

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.

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.

• Other: Goal directed haemodynamic treatment
  Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
  Other Names:

  • Dobutamine 0.2-10 μg/kg/min
  • Buffered Glucose 25 mg/ml 1 ml/kg/h
  • Ringer´s Acetate 2 ml/kg/h
  • Voluven 3 ml/kg as fluid challenge
  • Phenylephrine 50 μg for correction of hypotension
• Other: Routine fluid treatment
  Protocol guided fluid treatment used in the clinical routine
  Other Names:

  • Buffered Glucose 25 mg/ml 1ml/kg/h
  • Ringer´s Acetate 2 ml/kg/h
  • Voluven at the attending anaesthetist's discretion
  • Phenylephrine 50 μg for correction of hypotension

• Active Comparator: Routine fluid treatment
  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
  Intervention: Other: Routine fluid treatment
• Experimental: Goal directed haemodynamic treatment
  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
  Intervention: Other: Goal directed haemodynamic treatment

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.