Optimization Study of Cardiac Risk Patients With Hip Fracture
Preoperative Optimization of the High-Risk Patient Undergoing Hip Fracture Surgery
1 other identifier
interventional
200
1 country
3
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedOctober 13, 2010
September 1, 2010
2 years
September 9, 2010
October 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
during hospital stay (approximately 10 days)
Secondary Outcomes (3)
Mortality
30 days
Mortality
3 months
Length of hospital stay
7-14 days
Study Arms (2)
Preoperative Optimization
ACTIVE COMPARATORPatients 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 INTERVENTIONPatients 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.
Interventions
: 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Linkoepinglead
- Region Örebro Countycollaborator
- Ryhov County Hospitalcollaborator
Study Sites (3)
Department of Anaesthesia & Intensive Care
Jönköping, SE-50185, Sweden
Department of Anaesthesia & Intensive Care, University Hospital
Linköping, SE-58185, Sweden
Department of Anaesthesia & Intensive Care, University Hospital
Örebro, SE-70185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christina Eintrei, Professon
Department of Medical & Health Sciences Division of Drug Research/Anaesthesiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2010
First Posted
October 13, 2010
Study Start
January 1, 2011
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
October 13, 2010
Record last verified: 2010-09