Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

Femoral Fracture Clinical Trial

— GDHT  

Official title:

Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01141894
• Other study ID #: 2009-018087-10
• Secondary ID: ID: 2008-1240-31
• Status: Terminated
• Phase: N/A
• Start date: March 2010
• Est. completion date: October 2014

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

Other:
• Goal directed haemodynamic treatment
Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
• Routine fluid treatment
Protocol guided fluid treatment used in the clinical routine

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with postoperative complications	absolute value, number	up to 2 weeks
Secondary	Health Related Quality of Life	European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively	1 year
Secondary	number of complications	absolute value number	4 months
Secondary	number of complications	absolute value number	12 months
Secondary	health related quality of life		4 months
Secondary	health related quality of life	absolute value number	12 months
Secondary	haemodynamic parameters	monitor readings from LiDCO plus	baseline