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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-018087-10-SE
Enrollment
Unknown
Registered
2009-12-22
Start date
2010-01-29
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffering from proximal femoral fracture.

Interventions

Trade Name: Ringer -Acetat BAxter Viaflo Product Name: Ringer -Acetat Pharmaceutical Form: Intravenous infusion Trade Name: Glukos Braun 50 mg/ml buffrad Product Name: Glukos Braun 50 mg/ml buffrad

Sponsors

Karolinska University Hospital Huddinge
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026