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Prevention of Myocardial Injury in Non-cardiac Surgery (PIXIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02344797
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Victoria Ekeløf Busch, Zealand University Hospital

Brief Summary:

Worldwide, more than 200 million patients have major non-cardiac surgery annually and a significant proportion of these patients suffer major cardiovascular complications (e.g. nonfatal myocardial infarction, cardiac arrest, vascular death) within 30 days of their surgery. Perioperative myocardial infarction is the most common cardiovascular complication and recent clinical studies have shown that even minor myocardial injury in relation to non-cardiac surgery is associated with 30-day mortality.

Remote ischemic preconditioning is a procedure, which protects remote tissues and organs e.g. against ischemia-reperfusion injury. Cycles of forearm or leg ischemia and reperfusion by the inflation of a blood-pressure cuff for brief periods are the preferred method.The aim of this interventional clinical study is to determine whether remote ischemic preconditioning can reduce markers of myocardial injury in emergent or urgent non-cardiac surgery.


Condition or disease Intervention/treatment Phase
Myocardial Injury Myocardial Infarction Procedure: Remote ischemic preconditioning Not Applicable

Detailed Description:

Patients with a hip fracture will be included in the study. The patients will be randomized to remote ischemic preconditioning or control (no intervention). The remote ischemic preconditioning procedure is carried out immediately after the induction of regional or general anesthesia. The blood pressure cuff is placed on the upper limb. The cuff is inflated to 200 mmHg resulting in a total occlusion of the blood flow to the limb. After 5 minutes of ischemia the cuff is deflated and the limb is reperfused for 5 minutes. The procedure is carried out 4 times in a row. For patients with systolic blood pressures >185 mmHg, the cuff will be inflated to at least 15 mmHg above the patient's systolic blood pressure.

The primary outcome is myocardial injury in noncardiac surgery within day 4 postoperatively.

We expect 15% of the patients in the placebo group to suffer myocardial injury while the incidence of myocardial injury is expected to be reduced to 7% in the intervention group. Type I error is set at 5% and type II error is set at 20%. In total 2 x 264 patients need to be included based on this power calculation. We will include patients until we have a total of 2 x 270 patients for evaluation (per-protocol).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 573 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Myocardial Injury by Remote Ischemic Preconditioning in Emergent or Urgent Non-cardiac Surgery: a Randomized Clinical Trial
Study Start Date : February 7, 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : August 24, 2018

Arm Intervention/treatment
Active Comparator: Intervention
Remote ischemic preconditioning, 4 cycles of 5 minutes ischemia and 5 minutes reperfusion of the forearm before surgery.
Procedure: Remote ischemic preconditioning
The remote ischemic preconditioning procedure is carried out immediately after the induction of regional or general anesthesia. The blood pressure cuff is placed on the upper limb. The cuff is inflated to 200 mmHg resulting in a total occlusion of the blood flow to the limb. After 5 minutes of ischemia the cuff is deflated and the limb is reperfused for 5 minutes. The procedure is carried out 4 times in a row. For patients with systolic blood pressures >185 mmHg, the cuff will be inflated to at least 15 mmHg above the patient's systolic blood pressure.

No Intervention: Control



Primary Outcome Measures :
  1. Number of patients with myocardial injury in non-cardiac surgery [ Time Frame: during surgery or the first 4 days after surgery ]

Secondary Outcome Measures :
  1. Peak plasma TnI and total TnI release (area under the curve) [ Time Frame: during surgery or the first 4 days after surgery ]
  2. Endothelial dysfunction (reactive hyperemia index) [ Time Frame: 24 hours after surgery ]
    Assessed by EndoPat

  3. Perioperative myocardial infarction [ Time Frame: 30 days, one year and 5 years after surgery ]
  4. Major adverse cardiovascular events [ Time Frame: 30 days, one year and 5 years after surgery ]
  5. Length of postoperative hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]
  6. Length of intensive care unit stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]
  7. All-cause mortality [ Time Frame: 30 days, one year and 5 years after surgery ]
  8. Biomarkers of coagulation [ Time Frame: preoperatively, 2 hours after incision, and on days 1 and 2 after surgery ]
  9. Plasma N-terminal Pro-Brain Natriuretic Peptide [ Time Frame: Preoperative and day 1 ]
    Plasma N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) before surgery and at day 1 after surgery.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients ≥ 45 years undergoing in-hospital hip fracture surgery
  • undergoing emergent or urgent surgery (i.e. emergent or urgent visitation to the Department of Orthopedic Surgery)
  • fulfil 1 or more of the following 4 inclusion criteria, which are all determined during the conversation with the patient:

    1. Ischemic heart disease, defined by any of the following criteria A. angina pectoris B. prior myocardial infarction C. prior percutaneous coronary intervention D. prior coronary artery bypass graft
    2. Peripheral arterial disease, defined by any of the following criteria A. intermittent claudication B. reduced peripheral arterial blood flow C. prior vascular surgery due to peripheral arterial disease
    3. Prior stroke OR
    4. any 1 of 7 risk criteria A. age ≥70 years; B. congestive heart failure C. prior transient ischemic attack; D. diabetes and currently taking an oral hypoglycemic agent or insulin E. hypertension G. preoperative serum creatinine >175 µmol/L (>2.0 mg/dl) H. smoking within 2 years of surgery

Exclusion Criteria:

  • History of peripheral arterial disease affecting both upper limbs
  • Renal failure with eGRF<30ml/min/1.73m2
  • Cardiogenic shock or cardiac arrest during the current hospital admission
  • Reoperation after elective surgery carried out during the current hospital admission
  • Not capable of giving informed consent after oral and written information
  • Other conditions that prevent the performance of remote ischemic preconditioning.
  • Previously included in this trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344797


Locations
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Denmark
Department of Anesthesia, Herlev Hospital
Herlev, Region H, Denmark, 2730
Depertment of Orthopedic Surgery, Holstebro Hospital
Holstebro, Region Midtjylland, Denmark, 7500
Department of Surgery, Koge Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Sarah E Busch, MD Department of Surgery, Koge Hospital, Denmark
  Study Documents (Full-Text)

Documents provided by Sarah Victoria Ekeløf Busch, Zealand University Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sarah Victoria Ekeløf Busch, MD, Ph.d. student, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02344797    
Other Study ID Numbers: SBpixie
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Keywords provided by Sarah Victoria Ekeløf Busch, Zealand University Hospital:
Perioperative
Postoperative Complications/prevention & control
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Wounds and Injuries
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases