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Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho) (PrEcho)

Primary Purpose

Echocardiography, Hip Fractures, Risk Assessment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FOCUS echocardiography
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Echocardiography focused on measuring FOCUS, Point-of-care echocardiography

Eligibility Criteria

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

Inclusion Criteria: Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2) Exclusion Criteria: Metastatic cancer and/or suspect pathological fracture. Concurrent other fracture/surgery. Reoperation within 72 hours from primary operation. Severe dementia. Preoperative echocardiography for other reason than participation in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard management

    FOCUS optimization

    Arm Description

    Standard preoperative management, no preoperative TTE

    Standard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings.

    Outcomes

    Primary Outcome Measures

    Blood pressure drop
    Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) < 60 mmHg

    Secondary Outcome Measures

    Change of blood pressure level
    Blood pressure (MAP) change from baseline BP
    Lowest level of blood pressure (MAP)
    Absolut lowest blood pressure (MAP) from baseline BP
    Acute kidney failure
    Acute kidney damage defined as a raise in serum creatinine according to the KDIGO-criteria
    Myocardial injury
    Myocardial injury defined as a raise in serum high-sensitive troponin with at least 5 ng/l-1 to a minimum concentration of at least 20 ng/l-1
    Readmission
    Readmission to hospital within 7 days
    Mortality
    Postoperative mortality at 7-, 30- and 90-days

    Full Information

    First Posted
    April 27, 2023
    Last Updated
    May 14, 2023
    Sponsor
    Umeå University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05862493
    Brief Title
    Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)
    Acronym
    PrEcho
    Official Title
    Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Umeå University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound (FOCUS) on intraoperative hypotension and postoperative complications in hip fracture surgery. Our hypothesis is that a preoperative FOCUS along with a hemodynamic optimization protocol will reduce the occurrence of intraoperative drops in blood pressure and post-operative complications.
    Detailed Description
    Hip fracture surgery is a common procedure, and despite progress in perioperative management, cardiac complications are common, and the post-operative mortality remains high. In this geriatric patient population, cardiac disease as well as varying degrees of dehydration is common, and preoperative knowledge of these conditions have a key role in enabling a proactive perioperative hemodynamic management. However, clinical assessment is surprisingly unreliable and has been shown to easily fail to identify significant cardiac disease and lack of venous return. Transthoracic echocardiography (TTE) is a well-established and non-invasive investigation that can identify cardiac disease and aberrations in volume status prior to surgery. In a preoperative practice, the use of focused cardiac ultrasound (FOCUS) enables an individualized anesthesia management and has been demonstrated to influence anesthesiologist decision making. Furthermore, measurements of inferior vena cava used as a surrogate for venous return have been shown to be a predictor of intraoperative hypotension. Patients scheduled for daytime hip fracture surgery will be screened for eligibility. Random allocation (1:1 allocation ratio) of patients to receive standard care (control group) or standard care + preoperative focused cardiac ultrasound with a preoperative hemodynamic optimization (intervention group). Registration of pre- and intraoperative blood pressure, as well as post-operative complications and mortality will be conducted. Primary outcome measure: Intraoperative hemodynamic instability defined as MAP < 60 mmHg.Secondary outcome measures: Time to surgery, length of hospital stay, renal failure, cardiac complications (myocardial ischemia, heart failure, post-operative atrial fibrillation, pulmonary edema, pulmonary embolism), 7-,30- and 90-day mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Echocardiography, Hip Fractures, Risk Assessment, Anesthesia, Hemodynamic Instability
    Keywords
    FOCUS, Point-of-care echocardiography

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a randomized, open label, superiority trial with a 1:1 allocation ratio
    Masking
    None (Open Label)
    Masking Description
    Blinded data analysis
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard management
    Arm Type
    No Intervention
    Arm Description
    Standard preoperative management, no preoperative TTE
    Arm Title
    FOCUS optimization
    Arm Type
    Experimental
    Arm Description
    Standard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    FOCUS echocardiography
    Intervention Description
    Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs
    Primary Outcome Measure Information:
    Title
    Blood pressure drop
    Description
    Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) < 60 mmHg
    Time Frame
    From date of randomization up to 4 hours
    Secondary Outcome Measure Information:
    Title
    Change of blood pressure level
    Description
    Blood pressure (MAP) change from baseline BP
    Time Frame
    From date of randomization up to 4 hours
    Title
    Lowest level of blood pressure (MAP)
    Description
    Absolut lowest blood pressure (MAP) from baseline BP
    Time Frame
    From date of randomization up to 4 hours
    Title
    Acute kidney failure
    Description
    Acute kidney damage defined as a raise in serum creatinine according to the KDIGO-criteria
    Time Frame
    From date of randomization up to 48 hours
    Title
    Myocardial injury
    Description
    Myocardial injury defined as a raise in serum high-sensitive troponin with at least 5 ng/l-1 to a minimum concentration of at least 20 ng/l-1
    Time Frame
    From date of randomization up to 48 hours
    Title
    Readmission
    Description
    Readmission to hospital within 7 days
    Time Frame
    From date of randomization up to 7 days
    Title
    Mortality
    Description
    Postoperative mortality at 7-, 30- and 90-days
    Time Frame
    From date of randomization up to 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2) Exclusion Criteria: Metastatic cancer and/or suspect pathological fracture. Concurrent other fracture/surgery. Reoperation within 72 hours from primary operation. Severe dementia. Preoperative echocardiography for other reason than participation in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tomi P Myrberg, MD, PhD
    Phone
    +4692028339
    Email
    tomi.myrberg@umu.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomi P Myrberg, MD, PhD
    Organizational Affiliation
    Umeå University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    SPSS data file will be available for a reasonable request

    Learn more about this trial

    Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

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