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Optimization Study of Cardiac Risk Patients With Hip Fracture

Primary Purpose

Left Ventricular Dysfunction, Femoral Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Colloids, dobutamin, levosimendan
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Left Ventricular Dysfunction focused on measuring NT-proBNP, non-cardiac surgery, left ventricular dysfunction, cardiac complications

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients > 65 yrs
  2. Proximal femur fracture where the patient is planned to be operated during the day (Monday-Friday).
  3. NT-proBNP > 900 ng/l in patients 65-75 yrs old, and >1800 ng/l in patients > 75 yrs.
  4. 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:

  1. Informed consent cannot be provided
  2. Mental or verbal difficulty in understanding or expressing willingness to participate in the study.
  3. Instable angina pectoris.
  4. Ongoing myocardial infarct or ischemia
  5. Circulatory shock
  6. Decompensated cardiac failure or pulmonary oedema
  7. Pathologic femur fracture
  8. Chronic haemodialysis
  9. Cardiac valve incompetence that has haemodynamic consequences

Any one of the above is a criterion for exclusion.

Sites / Locations

  • Department of Anaesthesia & Intensive Care
  • Department of Anaesthesia & Intensive Care, University Hospital
  • Department of Anaesthesia & Intensive Care, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Preoperative Optimization

Standard treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Mortality
all cause
Mortality
All cause
Length of hospital stay

Full Information

First Posted
September 9, 2010
Last Updated
October 12, 2010
Sponsor
University Hospital, Linkoeping
Collaborators
Region Örebro County, Ryhov County Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01219712
Brief Title
Optimization Study of Cardiac Risk Patients With Hip Fracture
Official Title
Preoperative Optimization of the High-Risk Patient Undergoing Hip Fracture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Linkoeping
Collaborators
Region Örebro County, Ryhov County Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction, Femoral Fracture
Keywords
NT-proBNP, non-cardiac surgery, left ventricular dysfunction, cardiac complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative Optimization
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Colloids, dobutamin, levosimendan
Other Intervention Name(s)
Optimization, Hip fracture, Left ventricular dysfunction, Cardiac complication
Intervention Description
: 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
Primary Outcome Measure Information:
Title
Major cardiac complications
Description
myocardial injury (Troponin T ≥ 0.04 μg/l and/or myocardial infarct or death from cardiac complications or therapy-requiring cardiac failure)
Time Frame
during hospital stay (approximately 10 days)
Secondary Outcome Measure Information:
Title
Mortality
Description
all cause
Time Frame
30 days
Title
Mortality
Description
All cause
Time Frame
3 months
Title
Length of hospital stay
Time Frame
7-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Oscarsson, MD, PhD
Phone
+46-10-1037784
Email
anna.oscarsson.tibblin@lio.se
First Name & Middle Initial & Last Name or Official Title & Degree
Anil Gupta, MD, PhD
Phone
+46-19-6020256
Email
anil.gupta@orebroll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Eintrei, Professon
Organizational Affiliation
Department of Medical & Health Sciences Division of Drug Research/Anaesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesia & Intensive Care
City
Jönköping
ZIP/Postal Code
SE-50185
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Junelind, MD
Phone
+46-36-321000
Email
johan.junelind@lj.se
First Name & Middle Initial & Last Name & Degree
Christer Oldin, MD
Phone
+46-36-321000
Email
christer.oldin@lj.se
First Name & Middle Initial & Last Name & Degree
Johan Junelind, MD
First Name & Middle Initial & Last Name & Degree
Christer Oldin, MD
Facility Name
Department of Anaesthesia & Intensive Care, University Hospital
City
Linköping
ZIP/Postal Code
SE-58185
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Oscarsson, MD, PhD
Phone
+46-10-1030000
Ext
7784
Email
anna.oscarsson.tibblin@lio.se
First Name & Middle Initial & Last Name & Degree
Maria Sörliden, MD
Phone
+46-1031000
Email
maria.sorliden@lio.se
First Name & Middle Initial & Last Name & Degree
Anna Oscarsson, MD, PhD
First Name & Middle Initial & Last Name & Degree
Maria Sörliden, MD
First Name & Middle Initial & Last Name & Degree
Anna-Karin Strand, MD
Facility Name
Department of Anaesthesia & Intensive Care, University Hospital
City
Örebro
ZIP/Postal Code
SE-70185
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Gupta, MD, PhD
Phone
+46-196020256
Email
anil.gupta@orebroll.se
First Name & Middle Initial & Last Name & Degree
Jan Kuchalik, MD
Phone
+46-196020256
Email
jan.kuchalik@orebroll.se
First Name & Middle Initial & Last Name & Degree
Anil Gupta, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jan Kuchalik, MD

12. IPD Sharing Statement

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Optimization Study of Cardiac Risk Patients With Hip Fracture

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