Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention
Femoral Fracture
Other: Goal directed haemodynamic treatment
Other: Routine fluid treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • number of patients with postoperative complications [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: March 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141894

Locations
Sweden
Karolinska University Hospital
Huddinge, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Erzsebet Bartha, M.D Karolinska University Hospital, Huddinge, Dept. of Anestesiology and Intensive Care
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erzsebet Bartha, Medical Doctor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01141894     History of Changes
Other Study ID Numbers: 2009-018087-10, ID: 2008-1240-31
Study First Received: April 20, 2010
Last Updated: March 31, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Proximal Femoral Fracture

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries
Dobutamine
Oxymetazoline
Phenylephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014