Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

Not Applicable

Terminated

• Conditions: Femoral Fracture
• Interventions: Other: Routine fluid treatment; Other: Goal directed haemodynamic treatment

• Registration Number: NCT01141894
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine fluid treatment	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
Goal directed haemodynamic treatment	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

Primary Outcome Measures

Name	Time	Method
number of patients with postoperative complications	up to 2 weeks	absolute value, number

Secondary Outcome Measures

Name	Time	Method
health related quality of life	12 months	absolute value number
haemodynamic parameters	baseline	monitor readings from LiDCO plus
Health Related Quality of Life	1 year	European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively
number of complications	12 months	absolute value number

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Huddinge, Sweden