- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01219712
Optimization Study of Cardiac Risk Patients With Hip Fracture
Preoperative Optimization of the High-Risk Patient Undergoing Hip Fracture Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jönköping, Sweden, SE-50185
- Department of Anaesthesia & Intensive Care
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Linköping, Sweden, SE-58185
- Department of Anaesthesia & Intensive Care, University Hospital
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Örebro, Sweden, SE-70185
- Department of Anaesthesia & Intensive Care, University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Pathologic femur fracture
- Chronic haemodialysis
- Cardiac valve incompetence that has haemodynamic consequences
Any one of the above is a criterion for exclusion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Preoperative Optimization
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.
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. |
: The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2.
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
Other Names:
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No Intervention: Standard treatment
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.
|
: The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2.
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major cardiac complications
Time Frame: during hospital stay (approximately 10 days)
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myocardial injury (Troponin T ≥ 0.04 μg/l and/or myocardial infarct or death from cardiac complications or therapy-requiring cardiac failure)
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during hospital stay (approximately 10 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days
|
all cause
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30 days
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Mortality
Time Frame: 3 months
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All cause
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3 months
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Length of hospital stay
Time Frame: 7-14 days
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7-14 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christina Eintrei, Professon, Department of Medical & Health Sciences Division of Drug Research/Anaesthesiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Leg Injuries
- Hip Injuries
- Femoral Fractures
- Fractures, Bone
- Hip Fractures
- Ventricular Dysfunction
- Ventricular Dysfunction, Left
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Protective Agents
- Cardiotonic Agents
- Phosphodiesterase Inhibitors
- Phosphodiesterase 3 Inhibitors
- Simendan
Other Study ID Numbers
- Hip-Op 101a
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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