Goal Directed fluid substitution at patients with proximal femoral fracture. Evaluation of costs and consequences of alternative strategies of intra -opertaive fluid substitution- randomised clinical trial - Goal directed fluid substitution at patients with proximal femoral fracture

• Conditions: Patients suffering from proximal femoral fracture.

• Registration Number: EUCTR2009-018087-10-SE
• Lead Sponsor: Karolinska University Hospital Huddinge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients (men and women) age > 70 years old
- Patients scheduled for operation of proximal femoral fracture during office hours
- Patient- judge by the investigator-who are presumed willing to participate or have a written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with a concomitant medication of Lithium
- Known allergy (or hypertensensitivity) to Lithium, or component of the medical device
- Patients weight < 40kg
- Patients with other conditiond or symtoms preventing the subject from entering the study, according to investigators judgement
- Patients with life expectancy less than 6 months and /or pathological fractures
- Patients not possible to insert arterial line

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Number of patients who died during the period of 30 days after surgery;Main Objective: Primary objective: evaluate the 30 days mortality in patients with proximal femoral fracture.;Secondary Objective: the secondary objectives are to estimate, the total volume of given per operative fluid, the needs of vasoactive and or inotropic spport, haemodynamic parameters, the number of complications and mortality. Also the per-operative costs, use of social services and health care services up to 12 months. Laboratory findings that are going to be compared: pro BNP, hs CRP, IL6; IL1 ;IL10 and other biomarkers.