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Hypertonic Lactate After Cardiac Arrest (LATTE)

Primary Purpose

Cardiac Arrest, Ischemia Reperfusion Injury, Anoxic Brain Injury

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sodium Lactate Solution
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring sodium lactate, cerebral metabolism

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years old
  • Sustained (> 20 minutes) return of spontaneous circulation (ROSC)
  • Comatose (GCS < 9)
  • Time to ROSC > 15'

Exclusion Criteria:

  • Protected categories (Pregnant women, Prisoners)
  • Anticipated withdrawal of support within 24 hours
  • Traumatic cause of cardiac arrest
  • time from ROSC to inclusion > 1hour
  • Inclusion in any other interventional trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    standard of care

    treatement group

    Arm Description

    Patients will receive the standard of care infusion (balanced crystalloids)

    half molar sodium lactate infusion 15 µmol/Kg/min

    Outcomes

    Primary Outcome Measures

    serum NSE
    NSE serum levels

    Secondary Outcome Measures

    ICU free days
    number of days free from intensive care unit
    Mortality
    mortality
    Neurological outcome
    Neurological outcome measured by Glasgow Outcome Scale at 90 days
    Hospital length of stay
    Hospital length of stay
    Severe adverse events rate
    Serious adverse events rate
    Need for Vasopressors
    Need for vasopressors during hospitalization
    Seizure rate
    Seizure rate
    Changes in cardiac biomarkers
    Troponin I serum levels
    Changes in brain biomarkers
    brain biomarkers including nfL and GFAP
    Changes in brain metabolism
    Brain metabolism measured by PET-IRM
    Changes in brain perfusion
    brain perfusion measured with early perfusion CT scan
    Changes in echocardiographic parameters (systolic)
    Changes systolic cardiac function assessed by echocardiography
    Changes in echocardiographic parameters (diastolic)
    Changes diastolic cardiac function assessed by echocardiography
    identification of optimal perfusion pressure
    identification of optimal perfusion pressure with invasive neuromonitoring
    identification of optimal cerebral oxygen tension
    identification of optimal cerebral oxygen tension with invasive neuromonitoring

    Full Information

    First Posted
    July 30, 2021
    Last Updated
    August 9, 2021
    Sponsor
    Erasme University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05004610
    Brief Title
    Hypertonic Lactate After Cardiac Arrest
    Acronym
    LATTE
    Official Title
    Hypertonic Lactate After Cardiac Arrest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    May 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Erasme University Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.
    Detailed Description
    Background: In resuscitated patients after cardiac arrest, ischemic brain injury and cardiac depression due to the reperfusion injury are accountable for high mortality rate and poor outcome. Hypertonic sodium lactate (HSL) solutions have been proven to be safe in healthy volunteers and they have shown some benefits in patients with traumatic brain injury and those with myocardial ischemia and could decrease the burden of hypoxic lesions in these organs. The aim of this phase II study is to investigate whether HSL administration could reduce organ damage related biomarkers in serum and if the administrations of these solutions is safe and feasible in resuscitated patients after cardiac arrest. Design: an investigator initiated, randomized, controlled, open label phase II clinical trial to test the safety and efficacy of the infusion of HSL in resuscitated patients after cardiac arrest admitted to the hospital. After resuscitation from CA, comatose patients will be screened for eligibility and randomized to receive either study treatment as HSL 0.5M infusion for 24h or standard of care. Expected outcomes: This controlled trial will assess the safety and efficacy of the 0.5 HSL infusion in a cohort of comatose resuscitated patients after cardiac arrest. The results of this trial may provide useful information for a larger phase III clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest, Ischemia Reperfusion Injury, Anoxic Brain Injury
    Keywords
    sodium lactate, cerebral metabolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    125 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    standard of care
    Arm Type
    No Intervention
    Arm Description
    Patients will receive the standard of care infusion (balanced crystalloids)
    Arm Title
    treatement group
    Arm Type
    Experimental
    Arm Description
    half molar sodium lactate infusion 15 µmol/Kg/min
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Lactate Solution
    Other Intervention Name(s)
    Hyperonic sodium lactate
    Intervention Description
    continuous intravenous infusion of half-molar sodium lactate
    Primary Outcome Measure Information:
    Title
    serum NSE
    Description
    NSE serum levels
    Time Frame
    48 hours after randomization
    Secondary Outcome Measure Information:
    Title
    ICU free days
    Description
    number of days free from intensive care unit
    Time Frame
    trough study completion, on average 30 days
    Title
    Mortality
    Description
    mortality
    Time Frame
    trough study completion before hospital discharge, on average 60 days
    Title
    Neurological outcome
    Description
    Neurological outcome measured by Glasgow Outcome Scale at 90 days
    Time Frame
    trough study completion, 90 days after randomization
    Title
    Hospital length of stay
    Description
    Hospital length of stay
    Time Frame
    trough study completion, on average 60 days
    Title
    Severe adverse events rate
    Description
    Serious adverse events rate
    Time Frame
    during study drug administration/day 28 or ICU discharge or death
    Title
    Need for Vasopressors
    Description
    Need for vasopressors during hospitalization
    Time Frame
    through study completion, on average 14 days
    Title
    Seizure rate
    Description
    Seizure rate
    Time Frame
    through study completion before ICU discharge, on average 14 days
    Title
    Changes in cardiac biomarkers
    Description
    Troponin I serum levels
    Time Frame
    at randomization, 24 hours, 48 hours and 72 hours after randomization
    Title
    Changes in brain biomarkers
    Description
    brain biomarkers including nfL and GFAP
    Time Frame
    at randomization, after 24 hours, 48 hours and 72 hours
    Title
    Changes in brain metabolism
    Description
    Brain metabolism measured by PET-IRM
    Time Frame
    within 24h after randomization
    Title
    Changes in brain perfusion
    Description
    brain perfusion measured with early perfusion CT scan
    Time Frame
    within 24h after randomization
    Title
    Changes in echocardiographic parameters (systolic)
    Description
    Changes systolic cardiac function assessed by echocardiography
    Time Frame
    at randomization, at 24 hours and 48 hours after randomization
    Title
    Changes in echocardiographic parameters (diastolic)
    Description
    Changes diastolic cardiac function assessed by echocardiography
    Time Frame
    at randomization, at 24 hours and 48 hours after randomization
    Title
    identification of optimal perfusion pressure
    Description
    identification of optimal perfusion pressure with invasive neuromonitoring
    Time Frame
    through study completion, on average 30 days
    Title
    identification of optimal cerebral oxygen tension
    Description
    identification of optimal cerebral oxygen tension with invasive neuromonitoring
    Time Frame
    through study completion, on average 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years old Sustained (> 20 minutes) return of spontaneous circulation (ROSC) Comatose (GCS < 9) Time to ROSC > 15' Exclusion Criteria: Protected categories (Pregnant women, Prisoners) Anticipated withdrawal of support within 24 hours Traumatic cause of cardiac arrest time from ROSC to inclusion > 1hour Inclusion in any other interventional trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Filippo Annoni, MD
    Phone
    0483141483
    Email
    filippo.annoni@erasme.ulb.ac.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabio S Taccone, MD,PhD
    Email
    fabio.tacconei@erasme.ulb.ac.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Filippo Annoni, MD
    Organizational Affiliation
    Hôpital Erasme
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD may be available on reasonable request to other researchers

    Learn more about this trial

    Hypertonic Lactate After Cardiac Arrest

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