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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
Protocol guided fluid treatment used in the clinical routine
Karolinska University Hospital
Huddinge, Sweden
number of patients with postoperative complications
absolute value, number
Time frame: up to 2 weeks
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
Time frame: 1 year
number of complications
absolute value number
Time frame: 4 months
number of complications
absolute value number
Time frame: 12 months
health related quality of life
Time frame: 4 months
health related quality of life
absolute value number
Time frame: 12 months
haemodynamic parameters
monitor readings from LiDCO plus
Time frame: baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.