Optimization Study of Cardiac Risk Patients With Hip Fracture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Hospital, Linkoeping.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University Hospital Orebro
Ryhov County Hospital
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01219712
First received: September 9, 2010
Last updated: October 12, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Left Ventricular Dysfunction
Femoral Fracture
Procedure: Colloids, dobutamin, levosimendan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preoperative Optimization of the High-Risk Patient Undergoing Hip Fracture Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Major cardiac complications [ Time Frame: during hospital stay (approximately 10 days) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    all cause

  • Mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    All cause

  • Length of hospital stay [ Time Frame: 7-14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  • 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: Colloids, dobutamin, levosimendan

: 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

Other Names:
  • Optimization
  • Hip fracture
  • Left ventricular dysfunction
  • Cardiac complication
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.
Procedure: Colloids, dobutamin, levosimendan

: 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

Other Names:
  • Optimization
  • Hip fracture
  • Left ventricular dysfunction
  • Cardiac complication

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219712

Contacts
Contact: Anna Oscarsson, MD, PhD +46-10-1037784 anna.oscarsson.tibblin@lio.se
Contact: Anil Gupta, MD, PhD +46-19-6020256 anil.gupta@orebroll.se

Locations
Sweden
Department of Anaesthesia & Intensive Care Not yet recruiting
Jönköping, Sweden, SE-50185
Contact: Johan Junelind, MD    +46-36-321000    johan.junelind@lj.se   
Contact: Christer Oldin, MD    +46-36-321000    christer.oldin@lj.se   
Principal Investigator: Johan Junelind, MD         
Sub-Investigator: Christer Oldin, MD         
Department of Anaesthesia & Intensive Care, University Hospital Not yet recruiting
Linköping, Sweden, SE-58185
Contact: Anna Oscarsson, MD, PhD    +46-10-1030000 ext 7784    anna.oscarsson.tibblin@lio.se   
Contact: Maria Sörliden, MD    +46-1031000    maria.sorliden@lio.se   
Principal Investigator: Anna Oscarsson, MD, PhD         
Sub-Investigator: Maria Sörliden, MD         
Sub-Investigator: Anna-Karin Strand, MD         
Department of Anaesthesia & Intensive Care, University Hospital Not yet recruiting
Örebro, Sweden, SE-70185
Contact: Anil Gupta, MD, PhD    +46-196020256    anil.gupta@orebroll.se   
Contact: Jan Kuchalik, MD    +46-196020256    jan.kuchalik@orebroll.se   
Principal Investigator: Anil Gupta, MD, PhD         
Sub-Investigator: Jan Kuchalik, MD         
Sponsors and Collaborators
University Hospital, Linkoeping
University Hospital Orebro
Ryhov County Hospital
Investigators
Study Director: Christina Eintrei, Professon Department of Medical & Health Sciences Division of Drug Research/Anaesthesiology
  More Information

No publications provided

Responsible Party: Christina Eintrei, Department of Medical and Health Sciences, Division of drug research & anesthesiology
ClinicalTrials.gov Identifier: NCT01219712     History of Changes
Other Study ID Numbers: Hip-Op 101a
Study First Received: September 9, 2010
Last Updated: October 12, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital, Linkoeping:
NT-proBNP
non-cardiac surgery
left ventricular dysfunction
cardiac complications

Additional relevant MeSH terms:
Hip Injuries
Femoral Fractures
Fractures, Bone
Hip Fractures
Ventricular Dysfunction, Left
Ventricular Dysfunction
Wounds and Injuries
Leg Injuries
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014