Clinical Trial: Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Karolinska Institutet

Current Primary Outcome: number of patients with postoperative complications [ Time Frame: up to 2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Health Related Quality of Life [ Time Frame: 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 [ Time Frame: 4 months ]
  • number of complications [ Time Frame: 12 months ]
  • health related quality of life [ Time Frame: 4 months ]
  • health related quality of life [ Time Frame: 12 months ]
  • haemodynamic parameters [ Time Frame: baseline ]


Original Secondary Outcome:

  • Health Related Quality of Life [ Time Frame: 1 year ]
    EQ5D questionaire shall be registered preoperatively, at 4 and 12 months postoperatively
  • number of complications [ Time Frame: 4 months ]
  • number of complications [ Time Frame: 12 months ]
  • health related quality of life [ Time Frame: 4 months ]
  • health related quality of life [ Time Frame: 12 months ]
  • haemodynamic parameters [ Time Frame: baseline ]


Information By: Karolinska Institutet

Dates:
Date Received: April 20, 2010
Date Started: March 2010
Date Completion:
Last Updated: January 5, 2015
Last Verified: January 2015