NCT01141894

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Fracture

Interventions

Type	Name	Description
OTHER	Goal directed haemodynamic treatment	Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
OTHER	Routine fluid treatment	Protocol guided fluid treatment used in the clinical routine

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-03-01
• Completion: 2014-10-01
• First posted: 2010-06-11
• Last updated: 2020-09-18

Locations

1 site across 1 country: Sweden