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

September 16, 2020 updated by: Erzsebet Bartha, Karolinska Institutet

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Ringer´s Acetate 2 ml/kg/h
  • Phenylephrine 50 μg for correction of hypotension
  • Buffered Glucose 25 mg/ml 1ml/kg/h
  • Voluven at the attending anaesthetist's discretion
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
number of complications
Time Frame: 4 months
absolute value number
4 months
number of complications
Time Frame: 12 months
absolute value number
12 months
health related quality of life
Time Frame: 4 months
4 months
health related quality of life
Time Frame: 12 months
absolute value number
12 months
haemodynamic parameters
Time Frame: baseline
monitor readings from LiDCO plus
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Erzsebet Bartha, M.D, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (ESTIMATE)

June 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-018087-10
  • ID: 2008-1240-31 (OTHER: Ethical Board of Karolinska Institute Stockholm)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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