Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture (GDHT)

This study has been terminated.
(slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Erzsebet Bartha, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01141894
First received: April 20, 2010
Last updated: March 31, 2014
Last verified: March 2014

April 20, 2010
March 31, 2014
March 2010
March 2014   (final data collection date for primary outcome measure)
number of patients with postoperative complications [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141894 on ClinicalTrials.gov Archive Site
  • Health Related Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • number of complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • health related quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • health related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • haemodynamic parameters [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Health Related Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    EQ5D questionaire shall be registered preoperatively, at 4 and 12 months postoperatively
  • number of complications [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • number of complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • health related quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • health related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • haemodynamic parameters [ Time Frame: baseline ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Femoral Fracture
  • Other: Goal directed haemodynamic treatment
    Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
    Other Names:
    • Dobutamine 0.2-10 μg/kg/min
    • Buffered Glucose 25 mg/ml 1 ml/kg/h
    • Ringer´s Acetate 2 ml/kg/h
    • Voluven 3 ml/kg as fluid challenge
    • Phenylephrine 50 μg for correction of hypotension
  • Other: Routine fluid treatment
    Protocol guided fluid treatment used in the clinical routine
    Other Names:
    • Buffered Glucose 25 mg/ml 1ml/kg/h
    • Ringer´s Acetate 2 ml/kg/h
    • Voluven at the attending anaesthetist's discretion
    • Phenylephrine 50 μg for correction of hypotension
  • Active Comparator: 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
    Intervention: Other: Routine fluid treatment
  • Experimental: 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
    Intervention: Other: Goal directed haemodynamic treatment
Bartha E, Davidson T, Brodtkorb TH, Carlsson P, Kalman S. Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients. Trials. 2013 Jul 9;14:205. doi: 10.1186/1745-6215-14-205.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
June 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01141894
2009-018087-10, ID: 2008-1240-31
Yes
Erzsebet Bartha, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Erzsebet Bartha, M.D Karolinska University Hospital, Huddinge, Dept. of Anestesiology and Intensive Care
Karolinska Institutet
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP