Femoral FractureGDHTNCT01141894
Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture
A study testing Goal directed haemodynamic treatment and Routine fluid treatment in people with Femoral Fracture, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- Goal directed haemodynamic treatment and Routine fluid treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoral Fracture
- Being tested
- Goal directed haemodynamic treatment, Routine fluid treatment
- Keywords
- Proximal Femoral Fracture
- Medical subject headings
- Femoral Fractures, Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed haemodynamic treatmentOther
Also called 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
Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
Routine fluid treatmentOther
Also called 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
Protocol guided fluid treatment used in the clinical routine
| Study group | Role | What they receive |
|---|---|---|
| Routine fluid treatment | Active comparator | 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 Receives: Other: Routine fluid treatment |
| Goal directed haemodynamic treatment | Experimental | 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 Receives: Other: Goal directed haemodynamic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with postoperative complications
absolute value, number
Measured: up to 2 weeks
Secondary outcomes (6)
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
Measured: 1 year
number of complications
absolute value number
Measured: 4 months
number of complications
absolute value number
Measured: 12 months
health related quality of life
Measured: 4 months
health related quality of life
absolute value number
Measured: 12 months
haemodynamic parameters
monitor readings from LiDCO plus
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completionOct 2014
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoral FractureStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erzsebet Bartha, Karolinska Institutet
- Investigators
- Erzsebet Bartha, M.D, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141894
- Sponsor's protocol ID
- 2009-018087-10
- Other IDs
- ID: 2008-1240-31, 2009
- Acronym
- GDHT
- Status last verified
- Sep 2020
- First submitted
- 20 Apr 2010
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26994228Bartha 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.
PubMed 23837606
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01141894
- Acronym / sponsor ID
- GDHT / 2009-018087-10
- Conditions
- Femoral Fracture
- Keywords
- Proximal Femoral Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine fluid treatment | Active comparator | Other: Routine fluid treatmentBuffered 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 | Experimental | Other: Goal directed haemodynamic treatmentGoal 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal directed haemodynamic treatmentAlso: 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 challengeTreatment by fluids and Dobutamine to attain fixed haemodynamic goal | Other | Goal directed haemodynamic treatment |
| Routine fluid treatmentAlso: 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 hypotensionProtocol guided fluid treatment used in the clinical routine | Other | Routine fluid treatment |
Primary outcome
number of patients with postoperative complications
Time frame: up to 2 weeks
absolute value, number
6 secondary outcomes
Health Related Quality of Life
Time frame: 1 year
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
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Derived from this study: PubMed 26994228Bartha 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.
- Derived from this study: PubMed 23837606Bartha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erzsebet Bartha, M.D principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal directed haemodynamic treatment and Routine fluid treatment in people with Femoral Fracture, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with postoperative complications (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01141894, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.