Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01141894

Acronym

GDHT

Enrollment

150

Registered

2010-06-11

Start date

2010-03-31

Completion date

2014-10-31

Last updated

2020-09-18

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

Conditions

Femoral Fracture

Keywords

Proximal Femoral Fracture

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.

Interventions

OTHERGoal directed haemodynamic treatment

Treatment by fluids and Dobutamine to attain fixed haemodynamic goal

OTHERRoutine fluid treatment

Protocol guided fluid treatment used in the clinical routine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
number of patients with postoperative complications	up to 2 weeks	absolute value, number

Secondary

Measure	Time frame	Description
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	4 months	absolute value number
health related quality of life	4 months	—
haemodynamic parameters	baseline	monitor readings from LiDCO plus

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026