Left Ventricular DysfunctionNCT01219712
Optimization Study of Cardiac Risk Patients With Hip Fracture
A study testing Colloids, dobutamin, levosimendan in people with Left Ventricular Dysfunction and Femoral Fracture, run by University Hospital, Linkoeping at 3 sites in Sweden.
Trial summary
Elderly patients undergoing surgery for proximal hip fracture have a high risk of morbidity and mortality (M\&M) postoperatively. Several studies including some from the investigators department have shown that there is a high risk of cardiovascular complications in this group of patients and 3-month mortality is… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Femoral Fracture
- What is being tested?
- Colloids, dobutamin, levosimendan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2011to Feb 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients > 65 yrs
- Proximal femur fracture where the patient is planned to be operated during the day (Monday-Friday).
- NT-proBNP > 900 ng/l in patients 65-75 yrs old, and >1800 ng/l in patients > 75 yrs.
- Informed consent provided by the patient.
- All of the above criteria must be fulfilled before the patient can be included in the study.
Who cannot join
- Informed consent cannot be provided
- Mental or verbal difficulty in understanding or expressing willingness to participate in the study.
- Instable angina pectoris.
- Ongoing myocardial infarct or ischemia
- Circulatory shock
- Decompensated cardiac failure or pulmonary oedema
Show all 10Show fewer
- Pathologic femur fracture
- Chronic haemodialysis
- Cardiac valve incompetence that has haemodynamic consequences
- Any one of the above is a criterion for exclusion.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Department of Anaesthesia & Intensive Care
Jönköping, SE-50185
Johan Junelind, MD, +46-36-321000, johan.junelind@lj.se
Christer Oldin, MD, +46-36-321000, christer.oldin@lj.se
Department of Anaesthesia & Intensive Care, University Hospital
Linköping, SE-58185
Anna Oscarsson, MD, PhD, +46-10-1030000 ext. 7784, anna.oscarsson.tibblin@lio.se
Maria Sörliden, MD, +46-1031000, maria.sorliden@lio.se
Department of Anaesthesia & Intensive Care, University Hospital
Örebro, SE-70185
Anil Gupta, MD, PhD, +46-196020256, anil.gupta@orebroll.se
Jan Kuchalik, MD, +46-196020256, jan.kuchalik@orebroll.se
About this study
Official title: Preoperative Optimization of the High-Risk Patient Undergoing Hip Fracture Surgery
Elderly patients undergoing surgery for proximal hip fracture have a high risk of morbidity and mortality (M\&M) postoperatively. Several studies including some from the investigators department have shown that there is a high risk of cardiovascular complications in this group of patients and 3-month mortality is 15-20%. One of the causes of this high M\&M is the high incidence of cardiac failure associated with an increased NT-proBNP in this group of patients. The aim of the present study is to evaluate whether optimization of preoperative cardiac function can reduce cardiac M\&M postoperatively. Following verbal consent, patients with an increased NT-proBNP would be randomized to goal-directed preoperative optimization or standard management according to current hospital routines. Following optimization, the patients would be transferred to the operating rooms and subsequent management including perioperative patient management would be left to the discretion of a specialist anesthesiologist who is directly involved in patient care. Postoperatively, Troponin T and NT-proBNP would be measured in all patients according to the study protocol. In addition, major adverse cardiac events would be documented and follow-up would be done by after 30 days and 3 months postoperatively.
Read the detailed description
This is a prospective, open, randomized, multi-center study. Primary screening of patients would take place in the Emergency room or Orthopedic ward according to the inclusion and exclusion criteria (see below). All patients (>= 65 yr) with a proximal hip fracture would be required to provide either written or verbal informed consent prior to being included in the study. Subsequently, NT-proBNP would be taken and if this is above the recommended levels suggesting cardiac failure (> 900 ng/l in patients 65-75 yrs old, and >1800 ng/l in patients > 75 yrs), the patients may be included into the study. Included patients would then be randomized into two groups: Standard management according to existing hospital routines and Optimized Management Patients with a normal NT-proBNP would be listed but would not be included in the study. Patients with proximal femur fracture who are > 65 yrs old and have an increased NT-proBNP and who have given informed consent would be randomized to either Standard Management or Optimized Management. The former group would be managed according to the hospital routines and cared for by a Specialist Anaesthesiologist and Orthopaedic surgeon preoperatively.
Group O= Optimization Patients who are randomized to the Optimization group would be transferred to a Holding Area, which is close to the Operating Rooms 4-6 hours prior to planned surgery. The main aim of optimization is to achieve a normal oxygen delivery to the tissues preoperatively i.e. DO2: 500-600ml/min/m2. Optimized management means that patients first have an Echocardiography to evaluate myocardial function. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a Flo-track system (Vigileo, Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), as well as oxygen delivery (DO2).The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2.• Hb would be optimized to > 90 g/l
- SaO2 > 96%
- Stroke volume index (SVI) > 30
- Heart rate should ideally be < 80
Stroke volume index (SVI) > 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is < 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goa
The study would be done in three hospitals: University Hospital, Linköping, University Hospital, Örebro and Jönköping Hospital. A total of 200 patients (100 in each group) would be included. It is expected that the study would be ongoing during a period of two years.
- Conditions
- Left Ventricular Dysfunction, Femoral Fracture
- Being tested
- Colloids, dobutamin, levosimendan
- Keywords
- NT-proBNP, non-cardiac surgery, left ventricular dysfunction, cardiac complications
- Medical subject headings
- Ventricular Dysfunction, Left, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colloids, dobutamin, levosimendanProcedure or surgery
Also called Optimization, Hip fracture, Left ventricular dysfunction, Cardiac complication
: The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2.
- Hb would be optimized to > 90 g/l
- SaO2 > 96%
- Stroke volume index (SVI) > 30
- Heart rate should ideally be < 80
Stroke volume index (SVI) > 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is < 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goal
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Optimization | Active comparator | Patients with proximal femur fracture who are > 65 yrs old and have an increased NT-proBNP would be randomized to either Standard Management or Optimized Management.
The main aim of optimization is to achieve a normal oxygen delivery to the tissues preoperatively.
* Hb would be optimized to > 90 g/l
* SaO2 > 96%
* Stroke volume index (SVI) > 30
* Heart rate should ideally be < 80
Stroke volume index (SVI) > 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is < 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goal. Receives: Procedure: Colloids, dobutamin, levosimendan |
| Standard treatment | No intervention | Patients who are randomized to this group would be managed according to existing routines within the hospital. Consequently, these patients would be transferred to the Orthopaedic ward after initial management in the Emergency Department, including fluid therapy, oxygen and pain management. Since these patients have a significantly high NT-proBNP, a Cardiologist would be consulted and a decision for optimization taken together with the attending Anaesthesiologist and Orthopaedic Surgeon prior to surgery. Receives: Procedure: Colloids, dobutamin, levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiac complications
myocardial injury (Troponin T ≥ 0.04 μg/l and/or myocardial infarct or death from cardiac complications or therapy-requiring cardiac failure)
Measured: during hospital stay (approximately 10 days)
Secondary outcomes (3)
Mortality
all cause
Measured: 30 days
Mortality
All cause
Measured: 3 months
Length of hospital stay
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County, Ryhov County Hospital
- Investigators
- Christina Eintrei, Professon, Study director, Department of Medical & Health Sciences Division of Drug Research/Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219712
- Sponsor's protocol ID
- Hip-Op 101a
- Status last verified
- Sep 2010
- First submitted
- 9 Sep 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Optimization of the High-Risk Patient Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT01219712
- Acronym / sponsor ID
- Hip-Op 101a
- Conditions
- Left Ventricular Dysfunction, Femoral Fracture
- Keywords
- NT-proBNP, non-cardiac surgery, left ventricular dysfunction, cardiac complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Region Örebro County, Ryhov County Hospital
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 13 Oct 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.
Elderly patients undergoing surgery for proximal hip fracture have a high risk of morbidity and mortality (M\&M) postoperatively. Several studies including some from the investigators department have shown that there is a high risk of cardiovascular complications in this group of patients and 3-month mortality is 15-20%. One of the causes of this high M\&M is the high incidence of cardiac failure associated with an increased NT-proBNP in this group of patients. The aim of the present study is to evaluate whether optimization of preoperative cardiac function can reduce cardiac M\&M postoperatively. Following verbal consent, patients with an increased NT-proBNP would be randomized to goal-directed preoperative optimization or standard management according to current hospital routines. Following optimization, the patients would be transferred to the operating rooms and subsequent management including perioperative patient management would be left to the discretion of a specialist anesthesiologist who is directly involved in patient care. Postoperatively, Troponin T and NT-proBNP would be measured in all patients according to the study protocol. In addition, major adverse cardiac events would be documented and follow-up would be done by after 30 days and 3 months postoperatively.
Detailed description
This is a prospective, open, randomized, multi-center study. Primary screening of patients would take place in the Emergency room or Orthopedic ward according to the inclusion and exclusion criteria (see below). All patients (>= 65 yr) with a proximal hip fracture would be required to provide either written or verbal informed consent prior to being included in the study. Subsequently, NT-proBNP would be taken and if this is above the recommended levels suggesting cardiac failure (> 900 ng/l in patients 65-75 yrs old, and >1800 ng/l in patients > 75 yrs), the patients may be included into the study. Included patients would then be randomized into two groups: Standard management according to existing hospital routines and Optimized Management Patients with a normal NT-proBNP would be listed but would not be included in the study. Patients with proximal femur fracture who are > 65 yrs old and have an increased NT-proBNP and who have given informed consent would be randomized to either Standard Management or Optimized Management. The former group would be managed according to the hospital routines and cared for by a Specialist Anaesthesiologist and Orthopaedic surgeon preoperatively.
Group O= Optimization Patients who are randomized to the Optimization group would be transferred to a Holding Area, which is close to the Operating Rooms 4-6 hours prior to planned surgery. The main aim of optimization is to achieve a normal oxygen delivery to the tissues preoperatively i.e. DO2: 500-600ml/min/m2. Optimized management means that patients first have an Echocardiography to evaluate myocardial function. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a Flo-track system (Vigileo, Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), as well as oxygen delivery (DO2).The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2.• Hb would be optimized to > 90 g/l
- SaO2 > 96%
- Stroke volume index (SVI) > 30
- Heart rate should ideally be < 80
Stroke volume index (SVI) > 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is < 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goa
The study would be done in three hospitals: University Hospital, Linköping, University Hospital, Örebro and Jönköping Hospital. A total of 200 patients (100 in each group) would be included. It is expected that the study would be ongoing during a period of two years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Optimization | Active comparator | Procedure: Colloids, dobutamin, levosimendanPatients with proximal femur fracture who are > 65 yrs old and have an increased NT-proBNP would be randomized to either Standard Management or Optimized Management. The main aim of optimization is to achieve a normal oxygen delivery to the tissues preoperatively. * Hb would be optimized to > 90 g/l * SaO2 > 96% * Stroke volume index (SVI) > 30 * Heart rate should ideally be < 80 Stroke volume index (SVI) > 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is < 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goal. |
| Standard treatment | No intervention | Procedure: Colloids, dobutamin, levosimendanPatients who are randomized to this group would be managed according to existing routines within the hospital. Consequently, these patients would be transferred to the Orthopaedic ward after initial management in the Emergency Department, including fluid therapy, oxygen and pain management. Since these patients have a significantly high NT-proBNP, a Cardiologist would be consulted and a decision for optimization taken together with the attending Anaesthesiologist and Orthopaedic Surgeon prior to surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients > 65 yrs
- Proximal femur fracture where the patient is planned to be operated during the day (Monday-Friday).
- NT-proBNP > 900 ng/l in patients 65-75 yrs old, and >1800 ng/l in patients > 75 yrs.
- Informed consent provided by the patient.
- All of the above criteria must be fulfilled before the patient can be included in the study.
Key exclusion criteria (10 listed)
- Informed consent cannot be provided
- Mental or verbal difficulty in understanding or expressing willingness to participate in the study.
- Instable angina pectoris.
- Ongoing myocardial infarct or ischemia
- Circulatory shock
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 |
|---|---|---|
| Colloids, dobutamin, levosimendanAlso: Optimization, Hip fracture, Left ventricular dysfunction, Cardiac complication: The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2. * Hb would be optimized to > 90 g/l * SaO2 > 96% * Stroke volume index (SVI) > 30 * Heart rate should ideally be < 80 Stroke volume index (SVI) > 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is < 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goal | Procedure or surgery | Preoperative Optimization, Standard treatment |
Primary outcome
Major cardiac complications
Time frame: during hospital stay (approximately 10 days)
myocardial injury (Troponin T ≥ 0.04 μg/l and/or myocardial infarct or death from cardiac complications or therapy-requiring cardiac failure)
3 secondary outcomes
Mortality
Time frame: 30 days
Mortality
Time frame: 3 months
Length of hospital stay
Time frame: 7-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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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.
Christina Eintrei, Professon study director
Department of Medical & Health Sciences Division of Drug Research/Anaesthesiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colloids, dobutamin, levosimendan in people with Left Ventricular Dysfunction and Femoral Fracture, run by University Hospital, Linkoeping at 3 sites 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Oscarsson, MD, PhD (+46-10-1037784, anna.oscarsson.tibblin@lio.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiac complications (time frame: during hospital stay (approximately 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2010.