Clinical trial NCT01141894: Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture
Official title: Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Fracture
Keywords: Proximal Femoral Fracture
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: number of patients with postoperative complications
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 1 year
measure: number of complications
timeFrame: 4 months
measure: number of complications
timeFrame: 12 months
measure: health related quality of life
timeFrame: 4 months
measure: health related quality of life
timeFrame: 12 months
measure: haemodynamic parameters
timeFrame: baseline
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Erzsebet Bartha, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartha E, Arfwedson C, Imnell A, Kalman S. Towards individualized perioperative, goal-directed haemodynamic algorithms for patients of advanced age: observations during a randomized controlled trial (NCT01141894). Br J Anaesth. 2016 Apr;116(4):486-92. doi: 10.1093/bja/aew025.
citation: Bartha E, Davidson T, Brodtkorb TH, Carlsson P, Kalman S. Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients. Trials. 2013 Jul 9;14:205. doi: 10.1186/1745-6215-14-205.