Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture (GDHT)

Karolinska Institute

Status: Terminated

Conditions: Femoral Fracture

Treatments: Other: Routine fluid treatment; Other: Goal directed haemodynamic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01141894

ID: 2008-1240-31 (Other Identifier)

2009-018087-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Routine fluid treatment

Active Comparator group

Description:

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

Treatment:

Other: Routine fluid treatment

Goal directed haemodynamic treatment

Experimental group

Description:

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

Treatment:

Other: Goal directed haemodynamic treatment