Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Femoral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Routine fluid treatment

Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h and additionally as needed Voluven at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension

Group Type ACTIVE_COMPARATOR

Routine fluid treatment

Intervention Type OTHER

Protocol guided fluid treatment used in the clinical routine

Goal directed haemodynamic treatment

Goal directed haemodynamic treatment Dobutamine 0.2-10 μg/kg/min Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h Voluven 3 ml/kg as fluid challenge at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension

Group Type EXPERIMENTAL

Goal directed haemodynamic treatment

Intervention Type OTHER

Treatment by fluids and Dobutamine to attain fixed haemodynamic goal

Interventions

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Goal directed haemodynamic treatment

Treatment by fluids and Dobutamine to attain fixed haemodynamic goal

Intervention Type OTHER

Routine fluid treatment

Protocol guided fluid treatment used in the clinical routine

Intervention Type OTHER

Other Intervention Names

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Dobutamine 0.2-10 μg/kg/min Buffered Glucose 25 mg/ml 1 ml/kg/h Ringer´s Acetate 2 ml/kg/h Voluven 3 ml/kg as fluid challenge Phenylephrine 50 μg for correction of hypotension Buffered Glucose 25 mg/ml 1ml/kg/h Ringer´s Acetate 2 ml/kg/h Voluven at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No