Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Femoral Fracture
- Sponsor
- Karolinska Institutet
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- number of patients with postoperative complications
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Erzsebet Bartha
Medical Doctor
Karolinska Institutet
Eligibility Criteria
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.
Outcomes
Primary Outcomes
number of patients with postoperative complications
Time Frame: up to 2 weeks
absolute value, number
Secondary Outcomes
- health related quality of life(12 months)
- haemodynamic parameters(baseline)
- Health Related Quality of Life(1 year)
- number of complications(12 months)