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

Primary Purpose

Femoral Fracture

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Goal directed haemodynamic treatment
Routine fluid treatment
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fracture focused on measuring Proximal Femoral Fracture

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine fluid treatment

Goal directed haemodynamic treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

number of patients with postoperative complications
absolute value, number

Secondary Outcome Measures

Health Related Quality of Life
European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively
number of complications
absolute value number
number of complications
absolute value number
health related quality of life
health related quality of life
absolute value number
haemodynamic parameters
monitor readings from LiDCO plus

Full Information

First Posted
April 20, 2010
Last Updated
September 16, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01141894
Brief Title
Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture
Acronym
GDHT
Official Title
Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fracture
Keywords
Proximal Femoral Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine fluid treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Goal directed haemodynamic treatment
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Goal directed haemodynamic treatment
Other Intervention Name(s)
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
Intervention Description
Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
Intervention Type
Other
Intervention Name(s)
Routine fluid treatment
Other Intervention Name(s)
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
Intervention Description
Protocol guided fluid treatment used in the clinical routine
Primary Outcome Measure Information:
Title
number of patients with postoperative complications
Description
absolute value, number
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively
Time Frame
1 year
Title
number of complications
Description
absolute value number
Time Frame
4 months
Title
number of complications
Description
absolute value number
Time Frame
12 months
Title
health related quality of life
Time Frame
4 months
Title
health related quality of life
Description
absolute value number
Time Frame
12 months
Title
haemodynamic parameters
Description
monitor readings from LiDCO plus
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erzsebet Bartha, M.D
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26994228
Citation
Bartha E, Arfwedson C, Imnell A, Kalman S. Towards individualized perioperative, goal-directed haemodynamic algorithms for patients of advanced age: observations during a randomized controlled trial (NCT01141894). Br J Anaesth. 2016 Apr;116(4):486-92. doi: 10.1093/bja/aew025.
Results Reference
derived
PubMed Identifier
23837606
Citation
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.
Results Reference
derived

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Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

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